Recently Issued Guidance Documents
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Changes to Disposable Manufacturing Materials: Questions and Answers; Guidance for Industry
CDER/CBER/CVM, July 2022 -
Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding”; Draft Guidance for Industry
CDER/CBER, July 2022 -
Instructions for Use - Patient Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry
OCP/CDER/CBER, July 2022 -
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Draft Guidance for Industry
CDER/CBER/ORA, July 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Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry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Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders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Considerations for Rescinding Breakthrough Therapy Designation; Draft Guidance for Industry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 -
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry
CBER, June 2022 -
Electromagnetic Compatibility (EMC) of Medical Devices; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, June 2022 -
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Draft Guidance for Industry
CBER, May 2022 -
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry
(Updated May 23, 2022) CBER, May 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Risk Management Plans to Mitigate the Potential for Drug Shortages; Draft Guidance for Industry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Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry
CDER/CBER/CDRH/OCE, May 2022 -
Electronic Submission of IND Safety Reports Technical Conformance Guide; Guidance for Industry
CDER/CBER/OCE, April 2022 -
Crohn’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, April 2022 -
Ulcerative Colitis: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, April 2022 -
Providing Submissions in Electronic Format—Postmarketing Safety Reports; Guidance for Industry
CDER/CBER, April 2022 -
Drug Products, Including Biological Products, that Contain Nanomaterials; Guidance for Industry
CDER/CBER, April 2022 -
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet; Draft Guidance for Industry
CDER/CBER, April 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 -
E8(R1) General Considerations for Clinical Sutdies; Guidance for Industry
CDER/CBER, April 2022 -
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs; Guidance for Industry
CDER/CBER, April 2022 -
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, April 2022