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  1. Guidances | Drugs

Newly Added Guidance Documents

Below is a sortable list of the most recently added Guidance Documents.

You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

Newly Added Guidance Documents

Topic Guidance Status Date
  Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals Final 5/01/2021
Clinical - Medical Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment Final 6/29/2023
Compounding Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act Draft 6/27/2023
Advertising Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements Final 6/27/2023
Clinical - Medical Psychedelic Drugs: Considerations for Clinical Investigations Draft 6/23/2023
Administrative/Procedural Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act Draft 6/23/2023
Clinical - Medical Clinical Drug Interaction Studies with the Combined Oral Contraceptives Guidance for Industry Final 6/8/2023
ICH-Efficacy E6(R3) GOOD CLINICAL PRACTICE (GCP) Draft 6/7/2023
Generic Drugs Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Final 6/05/2023
Pharmacology/Toxicology Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals Final 6/05/2023
Clinical - Medical Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment Draft 6/02/2023
Clinical - Medical Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry Final 6/02/2023
Clinical - Medical Migraine: Developing Drugs for Preventive Treatment Draft 6/01/2023
Clinical - Medical Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Draft 5/26/2023
  Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Final 5/25/2023
Electronic Submissions Study Data Technical Conformance Guide - Technical Specifications Document Final 5/24/2023
Pharmacology/Toxicology Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Final 5/25/2023
Pharmacology/Toxicology Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information Draft 5/25/2023
Administrative/Procedural Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations Draft 5/18/2023
Administrative/Procedural Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act Draft 5/18/2023
  Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol  Final 5/8/2023
User Fees Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 Final 5/1/2023
ICH - Quality Q9(R1) Quality Risk Management Final 5/3/2023
Clinical - Medical Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft 5/3/2023
ICH-Safety S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS Final 5/1/2023
Clinical - Medical Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products Final 5/1/2023
Animal Rule Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment Draft 4/20/2023
Over the Counter Over-the-Counter Monograph Order Requests: Format and Content Draft 4/13/2023
Generics Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Draft 4/13/2023
Generics Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry Draft 4/13/2023
Administrative/Procedural A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Final 4/12/2023
Administrative/Procedural Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making Draft 4/5/2023
Administrative/Procedural Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act Draft 4/5/2023
Electronic Submissions Identification of Medicinal Products — Implementation and Use Final 3/30/2023
Administrative/Procedural Pharmacogenomic Data Submissions Draft 3/17/2023
Clinical - Medical Development of Local Anesthetic Drug Products With Prolonged Duration of Effect Draft 3/15/2023
Administrative/Procedural Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers Draft 3/15/2023
ICH - Quality  Q13 Continuous Manufacturing of Drug Substances and Drug Products Final 3/1/2023
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens Draft 3/1/2023
Clinical - Medical Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Draft 2/24/2023
Generics Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Draft 2/17/2023
ICH - Multidisciplinary M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms Draft 1/31/2023
Real World Data/Real World Evidence (RWD/RWE) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft 1/31/2023
Clinical - Pharmacology Acromegaly: Developing Drugs for Treatment Draft 1/30/2023
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry Final 1/23/2023
Clinical - Medical Mpox: Development of Drugs and Biological Products Draft 1/19/2023
Labeling Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Draft 1/12/2023
Drug Safety Format and Content of a REMS Document Final 1/4/2023
ICH - Multidisciplinary M11 Template: Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
ICH - Multidisciplinary M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
ICH - Multidisciplinary M11 Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
Generic Drugs Controlled Correspondence Related to Generic Drug Development Draft 12/21/2022
Labeling Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims Final 12/15/2022
Clinical-Antimicrobial Pulmonary Tuberculosis: Developing Drugs for Treatment Draft 12/14/2022
Generics Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry Final 12/14/2022
Compliance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry Final 12/7/2022
Clinical - Medical Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations Draft 12/6/2022
ICH-Safety E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials Final 12/5/2022
Generics Statistical Approaches to Establishing Bioequivalence Draft 12/2/2022
Generics ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions Draft 12/2/2022
Clinical-Antimicrobial Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act Final 11/18/2022
ICH-Quality Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Draft 11/10/2022
Generics Sameness Evaluations in an ANDA — Active Ingredients Draft 11/8/2022
Clinical - Medical M10 Bioanalytical Method Validation and Study Sample Analysis Final 11/4/2022
Clinical - Medical Cross Labeling Oncology Drugs in Combination Regimens Final 11/2/2022
ICH-Safety S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals Final 11/2/2022
User Fees Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program Draft 11/1/2022
Clinical - Medical Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials Draft 10/31/2022
Clinical - Antimicrobial Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention Draft 10/27/2022
Administrative/Procedural Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products Final 10/27/2022
Generics Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Draft  10/21/2022
Generics In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Biostatistics Multiple Endpoints in Clinical Trials Final 10/20/2022
Clinical - Medical Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA Final 10/13/2022
Generics Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA  Final 10/5/2022
Generics Competitive Generic Therapies Final 10/5/2022
Generics Facility Readiness: Goal Date Decisions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Final 10/3/2022
Electronic Submissions Providing Over-the-Counter Monograph Submissions in Electronic Format Draft 9/27/2022
Administrative/Procedural Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry Final 9/22/2022
Administrative/Procedural How To Obtain a Covered Product Authorization Draft 9/21/2022
Labeling Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products Draft 9/8/2022
Labeling Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products Draft 9/8/2022
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural		 Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products Final 9/8/2022
  E11A Pediatric Extrapolation Draft 8/26/2022
ICH-Multidisciplinary  M12 Drug Interaction Studies Draft 8/26/2022
ICH-Quality Q14 Analytical Procedure Development Draft 8/26/2022
ICH-Quality Q2(R2) Validation of Analytical ProceduresQ14 Analytical Procedure Development Draft 8/26/2022
ICH-Efficacy, ICH-Safety E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Final 8/26/2022    
Generics In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Biostatistics Multiple Endpoints in Clinical Trials Final 10/20/2022
Clinical - Medical Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA Final 10/13/2022
Generics Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA  Final 10/5/2022
Generics Competitive Generic Therapies Final 10/5/2022
Generics Facility Readiness: Goal Date Decisions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Final 10/3/2022
Electronic Submissions Providing Over-the-Counter Monograph Submissions in Electronic Format Draft 9/27/2022
Administrative/Procedural Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry Final 9/22/2022
Administrative/Procedural How To Obtain a Covered Product Authorization Draft 9/21/2022
Labeling Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products Draft 9/8/2022
Labeling Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products Draft 9/8/2022
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural		 Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products Final 9/8/2022
  E11A Pediatric Extrapolation Draft 8/26/2022
ICH-Multidisciplinary  M12 Drug Interaction Studies Draft 8/26/2022
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