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 In this section:

                Biologics Guidances

Biologics Guidances

                        Allergenics Guidances
          Blood Guidances
          Cellular & Gene Therapy Guidances
          Tissue Guidances
          Vaccine and Related Biological Product Guidances
          Xenotransplantation Guidances


                        General Biologics Guidances Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics Guidances
          Recently Issued Guidance DocumentsBiologics Guidances Recently Issued Guidance Documents
  
  	
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Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Draft Guidance for Industry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
	Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry
	CBER, December 2023
	Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers; Guidance for Industry
	CDER/CBER, December 2023
	Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry
	CDER/CBER, December 2023
	Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry
	CDER/CBER, December 2023
	Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
	CDER/CBER/OCE, December 2023
	Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders
	CDER/CBER/CDRH/OCE, December 2023
	Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry
	CDER/CBER, December 2023
	Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
	CDRH/CBER, December 2023
	Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry
	CDER/CBER, December 2023
	Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry
	CDER/CBER/ORA, December 2023
	Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry
	CBER, October 2023 (Updated November 27, 2023)
	COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry
	CDER/CBER, November 2023
	Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry
	CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, November 2023
	Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, November 2023
	Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, November 2023
	Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry
	CDER/CBER/CVM, October 2023
	Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Draft Guidance for Industry
	CDER/CBER/CDRH/CVM/OC, October 2023
	Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
	CBER, October 2023
	Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry
	CDER/CBER/CVM, October 2023
	Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry
	CBER, October 2023
	Investigational COVID-19 Convalescent Plasma; Guidance for Industry
	CBER, October 2023 (Updated October 13, 2023)
	Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, October 2023
	Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”; Guidance for Industry
	CDER/CBER, October 2023
	Electronic Submission Template for Medical Device De Novo Requests; Draft Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, September 2023
	Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment; Draft Guidance for Industry
	OCE/CDER/CBER/CDRH, September 2023
	Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry
	CDER/CBER, September 2023
	Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry
	CDER/CBER, September 2023
	Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards
	CDER/CBER/CDRH/OCE/OCLiP, September 2023
	Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1); Draft Guidance for Industry
	CDER/CBER, September 2023
	Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry
	CDER/CBER/CDRH/OCE/OCP, September 2023
	Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence; Draft Guidance for Industry
	CDER/CBER/OCE, September 2023
	Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry
	CDER/CBER, September 2023
	Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry
	CDER/CBER, September 2023
	Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, September 2023
	Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products; Guidance for IRBs and Clinical Investigators
	CDER/CBER/OCE, September 2023
	Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, September 2023
	Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff
	OCP/CDRH/CDER/CBER, September 2023
	DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry
	CDER/CBER/ORA, September 2023
	Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, September 2023
	Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, September 2023
	Evidentiary Expectations for 510(k) Implant Devices; Draft Guidance for Industry and Food and Drug Administration Staff
	CDRH/CBER, September 2023

                                                                                  Content current as of:
      01/30/2024
              
              
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical Devices
			     			  						              
			
			 
			  AllergenicsBiologics Guidances

          
                        Allergenics Guidances
          Blood Guidances
          Cellular & Gene Therapy Guidances
          Tissue Guidances
          Vaccine and Related Biological Product Guidances
          Xenotransplantation Guidances


                        General Biologics Guidances
 
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