Recently Issued Guidance Documents
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Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Draft Guidance for Industry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Risk Management Plans to Mitigate the Potential for Drug Shortages; Draft Guidance for Industry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Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry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Crohn’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry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Ulcerative Colitis: Developing Drugs for Treatment; Draft Guidance for Industry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Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet; Draft Guidance for Industry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Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry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Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff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 -
Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
(Updated March 31, 2022) CBER, March 2022 -
An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry
(Updated March 22, 2022) CBER, March 2022 -
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4; Guidance for Industry
CDER/CBER/CDRH/OCP, March 2022 -
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry
CBER, March 2022 -
Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry
CBER, March 2022 -
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry
CDER/CBER, March 2022 -
Inclusion of Older Adults in Cancer Clinical Trials
CDER/CBER/OCE, March 2022 -
Expansion Cohorts: Use in First-in-Human Clinical Trials; Guidance for Industry
CDER/CBER, March 2022 -
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry
CDER/CBER/OCE, March 2022 -
Drug Product Tracing: The Effect of Section 585 of the FD&C Act - Questions and Answers; Guidance for Industry
CDER/CBER/ORA, February 2022 -
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic; Guidance for Industry
CDER/CBER/OCE, February 2022 -
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER, February 2022 -
Population Pharmacokinetics; Guidance for Industry
CDER/CBER, February 2022 -
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry
CDER/CBER, February 2022 -
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format; Draft Guidance for Industry
CDER/CBER, February 2022