Recently Issued Guidance Documents

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• Considerations for Rescinding Breakthrough Therapy Designation; Draft Guidance for Industry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• Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry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• Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Draft Guidance for Industry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

• Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry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• Risk Management Plans to Mitigate the Potential for Drug Shortages; Draft Guidance for Industry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

• Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised); Guidance for Industry and Food and Drug Administration Staff
  CDRH/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• Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry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• Crohn’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry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• Ulcerative Colitis: Developing Drugs for Treatment; Draft Guidance for Industry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• Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet; Draft Guidance for Industry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