Administrative Guidances
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Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide; Guidance for Industry
CDER/CBER/CVM, February 2024 -
Charging for Investigational Drugs Under an IND: Questions and Answers; Guidance for Industry
CDER/CBER/OCE, February 2024 -
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act; Guidance for Industry
CDER/CBER/CVM, February 2024 -
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in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry
CDER/CBER, February 2024 -
Conducting Remote Regulatory Assessments Questions and Answers; Draft Guidance for Industry
ORA/OFPR/OCP/CBER/CDER/CDRH/OC/OCE/CFSAN/CTP/CVM, February 2024 -
Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry
CDER/CBER, December 2023 -
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry
CDER/CBER/ORA, December 2023 -
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/CVM/OC, October 2023 -
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry
CDER/CBER, September 2023 -
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry
CDER/CBER, September 2023 -
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff
OCP/CDRH/CDER/CBER, September 2023 -
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry
CDER/CBER/ORA, September 2023 -
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
CDER/CBER/ORA, September 2023 -
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry
CDER/CBER/ORA, August 2023 -
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies; Guidance for Industry
CDER/CBER/ORA, August 2023 -
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products; Draft Guidance for Industry
CDER/CBER, August 2023 -
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry
CDER/CBER, August 2023 -
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes; Guidance for Industry
CDER/CBER/OCE, May 2023 -
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry
CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, May 2023 -
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry
CDER/CBER, May 2023 -
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry
CDER/CBER, May 2023 -
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers; Guidance for Industry
CDER/CBER/CDRH/OCLiP/ORA, April 2023 -
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER/CDRH, April 2023 -
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 Guidance for Industry
CDER/CBER, April 2023 -
Pharmacogenomic Data Submissions; Draft Guidance for Industry
CDER/CBER/NCTR, March 2023 -
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Guidance for Industry
CDER/CBER, March 2023 -
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/CFSAN/CTP/CVM/ORA/OCLiP, March 2023 -
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER, February 2023 -
Format and Content of a REMS Document; Guidance for Industry
CDER/CBER, January 2023 -
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe; Guidance for Industry
CDER/CBER, December 2022 -
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Draft Guidance for Industry
CDER/CBER/OCLiP/OCE, November 2022 -
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products; Guidance for Industry
CDER/CBER/OCE, September 2022 -
Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry
CDER/CBER, July 2022 -
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER/CDRH, June 2022 -
Considerations for Rescinding Breakthrough Therapy Designation; Draft Guidance for Industry
CDER/CBER/OCE, June 2022 -
Risk Management Plans to Mitigate the Potential for Drug Shortages; Draft Guidance for Industry
CDER/CBER/CGMP, May 2022 -
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors; Guidance for Industry
CDER/CBER, May 2022 -
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, April 2022 -
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4; Guidance for Industry
CDER/CBER/CDRH/OCP, March 2022 -
Expansion Cohorts: Use in First-in-Human Clinical Trials; Guidance for Industry
CDER/CBER, March 2022 -
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry
CDER/CBER/OCE, March 2022 -
Drug Product Tracing: The Effect of Section 585 of the FD&C Act - Questions and Answers; Guidance for Industry
CDER/CBER/ORA, February 2022 -
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic; Guidance for Industry
CDER/CBER/OCE, February 2022 -
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER, February 2022 -
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry
CDER/CBER/CDRH, September 2021 -
FDA Export Certification; Guidance for Industry
CDER/CBER/CDRH/CFSAN/CVM, August 2021 -
Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies; Draft Guidance for Industry
CDER/CBER, June 2021 -
Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act; Draft Guidance for Industry
CDER/CBER, June 2021 -
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry
CDER/CBER/ORA, June 2021 -
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers; Guidance for Industry
CDER/CBER, March 2021 -
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
CDER/CBER, December 2020 -
Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry
CDER/CBER, December 2020 -
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Guidance for Industry
CDER/CBER, November 2020 -
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
CDER/CBER/ORA, October 2020 -
Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry
CDER/CBER, August 2020 -
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans; Guidance for Industry
CDER/CBER, July 2020 -
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic; Guidance for Industry
OCET/CDER/CBER/CDRH/CFSAN, March 2020 -
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products; Draft Guidance for Industry
CDER/CBER/CDRH/OCP, March 2020 -
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers; Guidance for Industry
CDER/CBER, March 2020 -
Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry
CDER/CBER/CDRH, December 2019 -
Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
CBER/CDER/ORA, December 2019 -
FDA Safe Importation Action Plan
OPPLA/CBER, December 2019 -
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act; Draft Guidance for Industry
OCE/CDER/CBER, December 2019 -
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Guidance for Industry
CDER/CBER/CDRH, October 2019 -
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy; Guidance for Industry
CDER/CBER/ORA, September 2019 -
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/CVM/CFSAN/CTP, July 2019 -
FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary; Guidance for Industry
CDER/CBER, April 2019 -
Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
OCP/CBER/CDER/CDRH, April 2019 -
REMS Assessment: Planning and Reporting; Draft Guidance for Industry
CDER/CBER, January 2019 -
Survey Methodologies to Assess REMS Goals That Relate to Knowledge; Draft Guidance for Industry
CDER/CBER, January 2019 -
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders
CDER/CBER, December 2018 -
Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry
CDER/CBER, December 2018 -
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry
CDER/CBER/OCE, September 2018 -
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff
CDER/CBER, September 2018 -
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry
CDER/CBER/ORA, September 2018 -
Product Identifier Requirements Under the Drug Supply Chain Security Act Compliance Policy; Guidance for Industry
CDER/CBER/ORA, September 2018 -
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry
CDER/CBER/OCE, August 2018 -
Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry
CDER/CBER/CDRH, July 2018 -
Limited Population Pathway for Antibacterial and Antifungal Drugs; Draft Guidance for Industry
CDER/CBER, June 2018 -
Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers; Guidance for Industry
CDER/CBER/CDRH/CVM/OC, June 2018 -
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers; Guidance for Industry and Review Staff
CDER/CBER/CDRH/OC, June 2018 -
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products; Draft Guidance for Industry
CDER/CBER, June 2018 -
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER, June 2018 -
Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry
CDER/CBER, June 2018 -
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry
CDER/CBER, June 2018 -
Development of a Shared System REMS; Draft Guidance for Industry
CDER/CBER, June 2018 -
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry
CDER/CBER/CDRH, April 2018 -
Special Protocol Assessment; Guidance for Industry
CDER/CBER, April 2018 -
Standardization of Data and Documentation Practices for Product Tracing; Draft Guidance for Industry
CDER/CBER/ORA, March 2018 -
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry
CDER/CBER, January 2018 -
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry
CDER/CBER, December 2017 -
Best Practices for Communication Between IND Sponsors and FDA During Drug Development; Guidance for Industry and Review Staff
CDER/CBER, December 2017 -
Use of a Drug Master File for Shared System REMS Submissions; Draft Guidance for Industry
CDER/CBER, November 2017 -
Formal Dispute Resolution: Appeals Above the Division Level; Guidance for Industry
CDER/CBER, November 2017 -
Individual Patient Expanded Access Applications: Form FDA 3926; Guidance for Industry
CDER/CBER, October 2017 -
Expedited Programs for Serious Conditions - Drugs and Biologics; Guidance for Industry
CDER/CBER, September 2017 -
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2017 (This document was originally issued on November 2, 2000.) -
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 -- Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/OC, June 2017 -
Dear Health Care Provider Letters: Improving Communication of Important Safety Information
CDER/CBER, February 2017 -
Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act - Compliance Policy; Guidance for Industry
CDER/CBER/ORA, February 2017 -
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft Guidance for Industry
CDER/CBER, January 2017 -
Use of Electronic Informed Consent in Clinical Investigations - Questions and Answers
OHRP/CDER/OGCP/CBER/CDRH, December 2016 -
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry
CDER/CBER/ORA, December 2016 -
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff
CDER/CBER/CDRH/CFSAN/CTP/NCTR, June 2016 -
Integrated Summary of Effectiveness
CDER/CBER, October 2015 -
DSCSA Implementation: Product Tracing Requirements for Dispensers - Compliance Policy Guidance for Industry
CDER/CBER/ORA, October 2015 -
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry
CDER/CBER, April 2015 -
User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Guidance for Industry
CDER/CBER, January 2015 -
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
CDER/CBER, December 2014 -
Specification of the Unique Facility Identifier (UFI) System for Drug Establishment
CDER/CBER/CVM/ORA, November 2014 -
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products - Recommended Practices; Draft Guidance for Industry
CDER/CBER/CVM, June 2014 -
Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide; Guidance for Industry
CDER/CBER, December 2012 -
Safety Reporting Requirements for INDs and BA/BE Studies ; Guidance for Industry and Investigators
CDER/CBER, December 2012 -
Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria; Guidance for Industry, FDA Staff, and Third Parties
CDRH/CBER, August 2009 (This document supersedes “Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria,” issued on October 4, 2004. )