Latest Federal Register Notices
Draft Guide on Clin-Pharm Considerations for Neonatals
Federal Register notice: FDA makes available a draft guidance entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.” 08/02/2019
Nonclinical Toxicology Studies Q & A Draft Guide
Federal Register notice: FDA makes available a draft guidance entitled “Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.” 08/02/2019
Guide on Developing Bacterial Vaginosis Drugs
Federal Register notice: FDA releases a final guidance on bacterial vaginosis drug development. 08/02/2019
Draft Guide on Drug Study General Considerations
Federal Register notice: FDA makes available a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” 08/01/2019
Drug User Fee Rates Set by FDA
Federal Register notice: FDA establishes the prescription drug user fee rates for fiscal year 2020. 08/01/2019
Info Collection Extension for Device GMPs
Federal Register notice: FDA seeks comments on an information collection extension for medical device GMP regulation. 07/31/2019
Info Collection Extension for UDI System
Federal Register notice: FDA seeks comments on an information collection extension for “Unique Device Identification (UDI) System — 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830.” 07/31/2019