Recently Issued Guidance Documents
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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 -
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The Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff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Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff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Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry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Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties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Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff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Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry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 -
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