Newly Released Guidance Documents
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Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry
CBER, November 2024 -
Drug Interaction Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry
CDER/CBER, October 2024 -
Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry
OCE/CDER/CBER, October 2024 -
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry
CDER/CBER/CDRH/OPT, October 2024 -
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 -
An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry
CBER, September 2024 -
The Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
CDRH/CBER, September 2024 -
Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2024 -
Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties
CDER/CBER/CDRH/OCE, September 2024 -
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry
CDER/CBER/OCE, September 2024 -
Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications; Guidance for Industry
CDER/CBER, September 2024 -
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties
CDRH/CBER, September 2024 -
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