US Federal Register - FDA Guidance Notices is an official public source that HealthSignal monitors for Pharmaceuticals, Medical Devices. The most recent updates we have tracked from it are listed below, each normalised into our index and linked back to the original publication on the source's own website.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeu...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence." This guidance provides recommenda...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #114 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Chickens--Gallus gallu...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #113 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Felines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #111 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Canines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #110 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Porcines." This guidan...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #109 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Equines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #97 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Caprines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #96 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Ovines." This guidance ...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #95 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Bovines." This guidance...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #90 entitled "Effectiveness of Anthelmintics: General Recommendations." This guidance has been dev...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological P...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biol...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 ...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer ...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA) is announcing the availability of the guidance "Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements." This guidance describes FDA's int...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Simil...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M15 General Principles for Model-Informed Drug Development." The guidance was prepared under t...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Edit...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Co...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA." This...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Content of Human Factors Information in Medical Device Marketing Submissions." This guidance provides a risk-...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence." This guidance provides recommendations...
US Federal Register - FDA Guidance NoticesIn response to a suggestion by Gilead Sciences, Inc. (Gilead) that was submitted to the public docket FDA-2008-N-0567 on February 14, 2022, the Food and Drug Administration (FDA or Agency) has analyzed whether hepatit...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)." The guidance was prepared u...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among ...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled "Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate That a New Infant Formula Supports the Quality Fac...
US Federal Register - FDA Guidance Notices