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Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry
CDER/CBER/CORH/CSFAN/CDT/CVM/ORA/OCLiP/OCE, October 2024
Container Closure System and Component Changes: Glass Vials and Stoppers; Guidance for Industry
CDER/CBER, July 2024
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
CDER/CBER/OCE, July 2024
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products; Draft Guidance for Industry and FDA Staff
CDER/CBER/CDRH/OCP, July 2024
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry
OCP/CBER/CDER/CDRH, June 2024
Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry
ORA/OCP/CBER/CDER/CDRH/CFSAN/CTP/CVM, June 2024
Platform Technology Designation Program for Drug Development; Draft Guidance for Industry
CDER/CBER, May 2024
REMS Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry
CDER/CBER, May 2024
Data Standards Catalog; Guidance for Industry
CDER/CBER//CDRH/CFSAN/CVM, April 2024
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER/OCE, March 2024
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards
CDER/CBER/CDRH/OCLiP/OHRP, March 2024
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in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry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Conducting Remote Regulatory Assessments Questions and Answers; Draft Guidance for Industry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
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. )
