| Procedural |
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs |
Rev. Draft |
03/09/2022 |
| Procedural |
Pre-Launch Activities Importation Requests (PLAIR) |
Final |
03/01/2022 |
| Procedural |
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry |
Final |
0301/2022 |
| Procedural |
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics |
Final |
03/01/2022 |
| Clinical / Medical |
Development of Non-Opioid Analgesics for Acute Pain |
Draft |
02/09/2022 |
| COVID-19 |
COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels |
Final |
02/08/2022 |
| Clinical Pharmacology |
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry |
Draft |
02/07/2022 |
| COVID-19 |
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic |
Final |
02/04/2022 |
| Procedural |
FDA’s guidance on uniform national policy (Section 585 of the FD&C Act) |
Final |
02/03/2022 |
| Clinical Pharmacology |
Population Pharmacokinetics |
Final |
02/03/2022 |
| Clinical / Medical |
Assessment of Pressor Effects of Drugs Guidance for Industry |
Draft |
02/03/2022 |
| Labeling |
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format |
Draft |
02/03/2022 |
| Procedural |
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs |
Draft |
2/01/2022 |
| Generics |
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry |
Draft |
1/25/2022 |
|
Technical Specifications Document
|
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH). |
Final |
1/21/2022 |
| Clinical / Medical |
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
|
Draft |
12/22/2021 |
| Pharmaceutical Quality / CMC |
Inspection of Injectable Products for Visible Particulates |
Draft |
12/16/2021 |
| Generics |
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry |
Draft |
12/10/2021 |
| Clinical / Medical |
Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products |
Draft |
12/10/2021 |
| ICH - Quality |
Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry |
Final |
12/10/2021 |
|
Pharmaceutical Quality / Chemistry, Manufacturing, and Controls (CMC)
|
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports |
Final |
12/09/2021 |
| Clinical / Medical |
Development of Anti-Infective Drug Products for the Pediatric Population |
Final |
12/09/2021 |
| Clinical / Medical |
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment |
Draft |
12/09/2021 |
| Real-World Data/Real-World Evidence (RWD/RWD) and Clinical/Medical |
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products |
Draft |
12/08/2021 |
| Clinical/Medical |
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations |
Draft |
12/07/2021 |
| CMC |
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators |
Draft |
12/07/2021 |
| Real-World Data/Real-World Evidence (RWD/RWD) and Clinical/Medical |
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products |
Draft |
11/29/2021 |
| Procedural |
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry |
Draft |
10/29/2021 |
| Procedural |
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide |
Draft |
10/29/2021 |
| RWD/RWE |
Data Standards for Drug and Biological Product Submissions Containing Real-World Data
Guidance for Industry |
Draft |
10/21/2021 |
| ICH - Quality |
Q13 Continuous Manufacturing of Drug Substances and Drug Products |
Draft |
10/13/2021 |
| ICH - Safety |
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals |
Draft |
10/6/2021 |
| Compounding |
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry |
Rev. Draft |
10/6/2021 |
| Administrative/Procedural |
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling |
Final |
9/30/2021 |
| Administrative/Procedural |
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers |
Final |
9/30/2021 |
| Administrative/Procedural |
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers |
Final |
9/30/2021 |
| ICH-Quality |
Q3B(R) Impurities in New Drug Products (Revision 3) |
Final |
9/29/2021 |
| Biologics |
Benefit-Risk Assessment for New Drug and Biological Products |
Draft |
9/29/2021 |
| Pharmaceutical Quality/ Microbiology Pharmaceutical Quality/ Manufacturing Standards (CGMP) |
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing |
Draft |
9/29/2021 |
| Drug Safety |
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices |
Draft |
9/29/2021 |
| Real World Data/Real World Evidence |
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products |
Draft |
9/28/2021 |
| Clinical/Antimicrobial |
Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment |
Draft |
9/2820/21 |
| Pharmaceutical Quality |
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry |
Draft |
9/20/2021 |
| Biosimilars |
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3) |
Draft |
9/17/2021 |
| Biosimilars |
Questions and Answers on Biosimilar Development and the BPCI Act |
Final |
9/17/2021 |
| ICH - Quality |
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry |
Final |
9/16/2021 |
| ICH - Safety |
S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS |
Draft |
9/13/2021 |
| Covid-19 |
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry |
Final |
9/8/2021 |
| Technical Specifications Document |
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) |
Final |
8/31/2021 |
| Covid-19 |
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency |
Rev. Final |
8/30/2021 |
| Generics |
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application |
Rev. Draft |
8/20/2021 |
| Pharmaceutical Quality - CMC |
Development and Submission of Near Infrared Analytical Procedures |
Final |
8/6/2021 |
| Clinical/Medical |
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials |
Final |
8/6/2021 |
| Clinical/Antimicrobial |
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry |
Draft |
7/28/2021 |
| Pharmaceutical Quality - CMC |
Field Alert Report Submission: Questions and Answers Guidance for Industry |
Final |
7/22/2021 |
| Clinical/Medical |
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications |
Draft |
7/1/2021 |
| Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Final |
7/1/2021 |
| Drug Safety |
Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry |
Draft |
6/25/2021 |
| Procedural |
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act |
Final |
6/3/2021 |
| Procedural |
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification |
Final |
6/3/2021 |
| Procedural |
Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act |
Final |
6/3/2021 |
| Labeling |
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers |
Final |
6/3/2021 |
| Pharmaceutical Quality - CMC and Labeling |
Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry |
Draft |
6/2/2021 |
| Pharmaceutical Quality - CMC |
Bispecific Antibody Development Programs Guidance for Industry |
Final |
5/24/2021 |
| ICH-Quality |
ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry |
draft |
5/20/2021 |
| Biostatistics |
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Guidance for Industry |
draft |
5/20/2021 |
| Generic Drugs |
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry |
draft |
5/19/2021 |
| Procedural |
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) |
Draft |
5/19/2021 |
| COVID-19 |
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry |
Final |
5/17/2021 |
| COVID-19- |
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention |
Final |
5/17/2021 |
| ICH- |
M9 Biopharmaceutics Classification System-Based Biowaivers |
Final |
5/11/2021 |
| ICH - |
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials |
Final |
5/11/2021 |
| ICH |
Q3D(R2) – Guideline for Elemental Impurities-Investigators |
Final |
5/11/2021 |
| ICH |
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals |
Final |
5/11/2021 |
| ICH |
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry |
Final |
5/11/2021 |
| ICH |
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex |
Final |
5/11/2021 |
| Pharm / Tox |
S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals |
Final |
5/11/2021 |
| Procedural |
Qualified Infectious Disease Product Designation Questions and Answers |
Draft |
5/11/2021 |
| Pharm / Tox |
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators |
Draft |
4/26/2021 |
| Covid-19 |
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/14/2021 |
| Covid-19 |
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry |
Final |
4/5/2021 |
| Covid-19 |
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers |
Final |
3/4/2021 |
| Covid-19 |
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) |
Final |
1/19/2021 |
| Covid-19 |
COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity |
Final |
1/13/2021 |
| Administrative / Procedural |
IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators |
Draft |
1/4/2021 |
| Over-the-Counter |
Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry |
Final |
12/30/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format--Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling |
Final |
12/23/2020 |
| Covid-19 |
Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
12/21/2020 |
| Clinical/Medical |
Dry Eye: Developing Drugs for Treatment Guidance for Industry |
Draft |
12/17/2020 |
| Generic Drugs |
Controlled Correspondence Related to Generic Drug Development Guidance for Industry |
Final |
12/16/2020 |
| Drug Safety |
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry |
Draft |
12/08/2020 |
| Drug Safety |
Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry |
Final |
12/08/2020 |
| Clinical Pharmacology |
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry |
Draft |
11/30/2020 |
| Generics |
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry |
Final |
11/24/2020 |
| Clinical /Medical |
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff |
Final |
11/24/2020 |
| Clinical Pharmacology |
Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry |
Draft |
11/20/2020 |
| Clinical/ Medical |
Cross Labeling Oncology Drugs in Combination Drug Regimens Guidance for Industry |
Draft |
11/19/2020 |
| Biosimilarity |
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act Guidance for Industry |
Draft |
11/19/2020 |
| User Feed |
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry |
Final |
11/09/2020 |
| Clinical / Medical |
Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry |
Final |
11/09/2020 |
| Pharm/Tox |
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry |
Final |
10/28/2020 |
| Generics |
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry |
Final |
10/27/2020 |
| Procedural |
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies Guidance for Industry |
Final |
10/22/2020 |
| Drug Safety |
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry |
Draft |
10/20/2020 |
| Clinical/Medical |
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry |
Final |
10/01/2020 |
| Pharmaceutical Quality/CMC |
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry |
Draft |
9/30/2020 |
| ICH-Safety /ICH-Efficacy |
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Guidance for Industry |
Draft |
9/29/2020 |
| Generics |
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry |
Draft |
9/28/2020 |
| Generics |
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs |
Final |
9/28/2020 |
| ICH-Multidisciplinary |
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers |
Draft |
9/28/2020 |
| Labeling |
Geriatric Information in Human Prescription Drug and Biological Product Labeling |
Draft |
9/15/2020 |
| Clinical/Medical |
Eosinophilic Esophagitis: Developing Drugs for Treatment |
Final |
9/15/2020 |
| COVID-19 Clinical/Medical |
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment |
Final |
9/14/2020 |
| COVID-19 |
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency |
Final |
9/10/2020 |
| Pharmaceutical Quality / CGMP |
Control of Nitrosamine Impurities in Human Drugs Guidance for Industry |
Final |
9/01/2020 |
| COVID-19 |
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry |
Final |
8/19/2020 |
| Procedural, Generics |
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Guidance for Industry |
Final |
8/18/2020 |
| Procedural |
Marketing Status Notifications Under Section 506I Guidance for Industry |
Final |
8/10/2020 |
| Clinical Pharmacology |
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry |
Draft |
8/7/2020 |
| Procedural |
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry |
Final |
8/5/2020 |
| Procedural |
Pediatric Study Plans:Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry |
Final |
7/31/2020 |
| Clinical/ Medical |
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval Guidance for Industry |
Final |
7/29/2020 |
| Labeling |
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry |
Draft |
7/29/2020 |
| Pharmaceutical Quality/CGMP |
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Guidance for Industry |
Final |
7/29/2020 |
| Chemistry, Manufacturing Control (CMC) |
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry |
Draft |
7/28/2020 |
| Pharmaceutical Quality/CMC |
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry |
Draft |
7/21/2020 |
| Clinical / Medical |
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections |
Final |
7/10/2020 |
| Clinical / Medical |
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies |
Final |
7/10/2020 |
| Clinical / Medical |
Cancer Clinical Trial Eligibility Criteria: Brain Metastases |
Final |
7/10/2020 |
| Clinical / Medical |
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients |
Final |
7/10/2020 |
| Clinical / Medical |
Development of Anti-Infective Drug Products for the Pediatric Population |
Draft |
6/29/2020 |
| Drug Safety |
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry |
Final |
6/29/2020 |
| Clinical / Antimicrobial |
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment |
Final |
6/24/2020 |
| Clinical / Antimicrobial |
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment |
Final |
6/24/2020 |
| COVID-19 |
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry |
Final |
6/19/2020 |
| COVID-19 |
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
6/17/2020 |
| Procedural |
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input |
Final |
6/16/2020 |
| Clinical / Medical |
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
6/2/2020 |
| Generics |
Orange Book Questions and Answers Guidance for Industry |
Draft |
5/29/2020 |
| ICH -Quality |
Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents |
Draft |
5/26/2020 |
| |
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products |
Final |
5/11/2020 |
| Clinical Medical |
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention |
Final |
5/11/2020 |
| Clinical / Antimicrobial |
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease Guidance for Industry |
Final |
5/7/2020 |
| Compounding, Clinical Medical |
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/30/2020 |
| Compounding |
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/22/2020 |
| Compounding, Pharmaceutical Quality |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/20/2020 |
| Compounding |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency |
Final |
4/16/2020 |
| Clinical / Medical |
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate |
Final |
4/13/2020 |
| Clinical / Medical |
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/10/2020 |
| Clinical / Medical |
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/09/2020 |
| User Fees |
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act |
Final |
4/03/2020 |
| Procedural |
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
Final |
3/27/2020 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP)/Over-the-Counter (OTC) |
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry |
Final |
3/24/2020 |
| Clinical / Medical |
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
Final |
3/22/2020 |
| Clinical / Medical |
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) |
Final |
3/19/2020 |
| Drug Safety |
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic |
Final |
3/19/2020 |
| Clinical / Medical |
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic |
Final |
3/18/2020 |
| Compounding |
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency |
Final |
3/14/2020 |
| Drug Safety |
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry |
Draft |
3/17/2020 |
| Genetics |
Competitive Generic Therapies Guidance for Industry |
Final |
3/13/2020 |
| Rare Diseases |
Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry |
Final |
3/13/2020 |
| ICH - Quality |
Q3D(R1) Elemental Impurities Guidance for Industry |
Final |
3/10/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Draft |
3/10/2020 |
| Clinical / Medical |
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control |
Draft |
3/9/2020 |
| Clinical / Medical |
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry |
Draft |
3/6/2020 |
| Pharmacology / Toxicology |
Safety Testing of Drug Metabolites Guidance for Industry |
Final, Revision 2 |
3/5/2020 |
| Procedural |
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers |
Final |
3/4/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications Revision 7 |
Final |
2/21/2020 |
| Pharm / Tox |
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry |
Revised Draft |
2/19/2020 |
| Biosimilarity |
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry |
Draft |
2/06/2020 |
| Clinical / Medical |
Mucopolysaccharidosis Type III (Sanfilippo Syndrome):Developing Drugs for Treatment Guidance for Industry |
Draft |
2/04/2020 |
| Advertising |
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry |
Draft |
2/3/2020 |
| Clinical / Antimicrobial |
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease Guidance for Industry |
Final |
5/7/2020 |
| Compounding, Clinical Medical |
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/30/2020 |
| Compounding |
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/22/2020 |
| Compounding, Pharmaceutical Quality |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/20/2020 |
| Compounding |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency |
Final |
4/16/2020 |
| Clinical / Medical |
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate |
Final |
4/13/2020 |
| Clinical / Medical |
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/10/2020 |
| Clinical / Medical |
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/09/2020 |
| User Fees |
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act |
Final |
4/03/2020 |
| Procedural |
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
Final |
3/27/2020 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP)/Over-the-Counter (OTC) |
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry |
Final |
3/24/2020 |
| Clinical / Medical |
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
Final |
3/22/2020 |
| Clinical / Medical |
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) |
Final |
3/19/2020 |
| Drug Safety |
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic |
Final |
3/19/2020 |
| Clinical / Medical |
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic |
Final |
3/18/2020 |
| Compounding |
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency |
Final |
3/14/2020 |
| Drug Safety |
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry |
Draft |
3/17/2020 |
| Genetics |
Competitive Generic Therapies Guidance for Industry |
Final |
3/13/2020 |
| Rare Diseases |
Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry |
Final |
3/13/2020 |
| ICH - Quality |
Q3D(R1) Elemental Impurities Guidance for Industry |
Final |
3/10/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Draft |
3/10/2020 |
| Clinical / Medical |
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control |
Draft |
3/9/2020 |
| Clinical / Medical |
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry |
Draft |
3/6/2020 |
| Pharmacology / Toxicology |
Safety Testing of Drug Metabolites Guidance for Industry |
Final, Revision 2 |
3/5/2020 |
| Procedural |
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers |
Final |
3/4/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications Revision 7 |
Final |
2/21/2020 |
| Pharm / Tox |
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry |
Revised Draft |
2/19/2020 |
| Biosimilarity |
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry |
Draft |
2/06/2020 |
| Clinical / Medical |
Mucopolysaccharidosis Type III (Sanfilippo Syndrome):Developing Drugs for Treatment Guidance for Industry |
Draft |
2/04/2020 |
| Advertising |
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry |
Draft |
2/3/2020 |
| Pharmaceutical Quality/CMC |
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry |
Draft |
11/1/2019 |
| Clinical / Medical |
Fabry Disease: Developing Drugs for Treatment Guidance for Industry |
Draft |
8/7/2019 |
| Pharmacology / toxicology |
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry |
Final |
8/1/2019 |
| Pharmacology / toxicology |
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers |
Draft |
7/31/2019 |
| International Council for Harmonisation - Efficacy |
E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES |
Draft |
7/31/2019 |
| Clinical / Antimicrobial |
Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry |
Final |
7/31/2019 |
| Clinical / Antimicrobial |
Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry |
Final |
7/31/2019 |
| Clinical / Antimicrobial |
Vulvovaginal Candidiasis: Developing Drugs for Treatment Guidance for Industry |
Final |
7/31/2019 |
| Clinical / Pharmacology |
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry |
Draft |
7/31/2019 |
| Clinical / Medical |
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry |
Final |
7/26/2019 |
| Clinical / Medical; Electronic Submissions |
Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document |
Final |
7/18/2019 |
| Clinical / Medical |
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry |
Draft Guidance |
7/17/2019 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry |
Draft Revision 7 |
7/16/2019 |
| Clinical/Medical |
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry |
Draft |
7/11/2019 |
| Clinical Pharmacology |
Population Pharmacokinetics Guidance for Industry |
Draft |
7/11/2019 |
| Pharmaceutical Quality/CMC |
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry |
Draft |
7/10/2019 |
| Pharmaceutical Quality/CMC |
Using the Inactive Ingredient Database Guidance for Industry |
Draft |
7/10/2019 |
| Drug Safety |
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry |
Final |
7/09/2019 |
| Compounding |
Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry |
Final |
7/05/2019 |
| Labeling |
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format Guidance for Industry |
Draft |
7/01/2019 |
| Labeling |
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry |
Draft |
7/01/2019 |
| Clinical / Medical |
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations Guidance for Industry |
Final |
6/28/2019 |
| Clinical / Medical |
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry |
Draft |
6/27/2019 |
| International Council on Harmonisation - Multidisciplinary |
M10 Bioanalytical Method Validation Guidance for Industry |
Draft |
6/26/2019 |
| International Council on Harmonisation - Efficacy |
E19 Optimisation of Safety Data Collection Guidance for Industry |
Draft |
6/26/2019 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF - 252KB) |
Final Guidance |
6/21/2019 |
| Clinical/Medical |
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry |
Draft |
6/20/2019 |
| Generics |
ANDA Submissions — Content and Format Guidance for Industry |
Final, Rev 1 |
6/12/2019 |
| Clinical/Medical |
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry |
Draft |
6/06/2019 |
| Clinical/Medical |
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry |
Draft |
6/06/2019 |
