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Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, August 2024
Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, August 2024
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, August 2024
Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, August 2024
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry
CDER/CBER, August 2024
Container Closure System and Component Changes: Glass Vials and Stoppers; Guidance for Industry
CDER/CBER, July 2024
Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry
OCE/CDER/CBER, August 2024
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry
OCE/CDER/CBER, August 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
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers; Draft Guidance for Industry
CDER/CBER, July 2024
Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry
CBER, July 2024
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Guidance for Industry
CBER, 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Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products; Draft Guidance for Industry and FDA Staff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
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Draft Guidance for Industry
OCE/CBER/CDER/CDRH/OMHHE/OWH, June 2024
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry
OCP/CBER/CDER/CDRH, June 2024
Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry
CDER/CBER, June 2024
Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry
CDER/CBER, 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
Remanufacturing of Medical Devices; Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff
CDRH/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
Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels; Guidance for Industry
CBER, April 2024
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry
CBER, April 2024
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, IRBs, and Clinical Investigators
OCE/CBER/CDER, April 2024
Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, IRBs, and Clinical Investigators
OCE/CBER/CDER, April 2024
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers; Draft Guidance for Industry
CDER/CBER, April 2024
Providing Regulatory Submissions in Electronic Format: IND Safety Reports; Guidance for Industry
CDER/CBER/OCE, April 2024
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER/OCE, March 2024
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 2024
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 2024
Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, March 2024
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry
CDER/CBER, 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
