Recently Issued Guidance Documents
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Platform Technology Designation Program for Drug Development; Draft Guidance for Industry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REMS Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry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Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry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Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, IRBs, and Clinical Investigators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Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, IRBs, and Clinical Investigators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and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers; Draft Guidance for Industry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Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff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Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff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Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry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Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards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