Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
Source: fda.gov
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Development and Licensure of Vaccines to Prevent COVID-19
This is the Guidance for Industry, Development and Licensure of Vaccines to Prevent COVID-19, CBER, Biologics
Source: fda.gov
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
This is the Guidance for Industry - Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
Drug Administration Guidance Issuing Office Docket Number Biologics Evaluation Voluntary Consensus Standards
Source: fda.gov
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
The guidance describes the enforcement policy for limited modifications to certain remote monitoring devices without prior submission of a 510(k).
Source: fda.gov
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements
This is the final guidance Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements
Drug Administration Guidance Issuing Office Public Health Emergency Docket Number Biologics Evaluation Federal Regulations
Source: fda.gov
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Revised)
Find answers to FAQs about demonstrating the substantial equivalence (SE) of a new tobacco product.
Source: fda.gov
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 (Revised)
Guidance on how manufacturers may establish that a tobacco product is grandfathered, or was commercially marketed in the U.S. as of February 15, 2007.
Source: fda.gov
Investigational COVID-19 Convalescent Plasma
FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
United States Drug Administration Public Health Service Act Guidance Issuing Office Docket Number Biologics Evaluation
Source: fda.gov
Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4)
This guidance document provides a list of questions that frequently have been asked about the requirements of the prior notice regulation, and the answers to those questions. It is being issued to help the food industry and others comply with the legal requirements.
United States Public Health Security Guidance Issuing Office Office Of Regulatory Affairs Drug Administration Docket Number
Source: fda.gov