Recently Issued Guidance Documents
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Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels; Guidance for Industry
CBER, April 2024 -
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry
CBER, April 2024 -
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, IRBs, and Clinical Investigators
OCE/CBER/CDER, April 2024 -
Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, IRBs, and Clinical Investigators
OCE/CBER/CDER, April 2024 -
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers; Draft Guidance for Industry
CDER/CBER, April 2024 -
Providing Regulatory Submissions in Electronic Format: IND Safety Reports; Guidance for Industry
CDER/CBER/OCE, April 2024 -
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER/OCE, March 2024 -
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 2024 -
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 2024 -
Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, March 2024 -
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry
CDER/CBER, March 2024 -
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards
CDER/CBER/CDRH/OCLiP/OHRP, March 2024 -
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide; Guidance for Industry
CDER/CBER/CVM, February 2024 -
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry
CDER/CBER, February 2024 -
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, February 2024 -
Charging for Investigational Drugs Under an IND: Questions and Answers; Guidance for Industry
CDER/CBER/OCE, February 2024 -
Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry
CDER/CBER/CDRH, February 2024 -
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act; Guidance for Industry
CDER/CBER/CVM, February 2024 -
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry
CDER/CBER, February 2024 -
Conducting Remote Regulatory Assessments Questions and Answers; Draft Guidance for Industry
ORA/OFPR/OCP/CBER/CDER/CDRH/OC/OCE/CFSAN/CTP/CVM, February 2024 -
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Draft Guidance for Industry
CDER/CBER/CDRH/OC/OCE/OMHHE/OWH/OCLiP/OPT, January 2024 -
Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry
CBER, January 2024 -
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Guidance for Industry
CBER, January 2024 -
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, January 2024