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Human Drugs

FDA Workshop on Evaluating RWE Observational Studies

FDA and the Duke-Margolis Center for Health Policy schedule a 2/16-17 virtual workshop on evaluating real-world evidence from observational studies in...

Medical Devices

FDA Approves MicroVentions WEB 17 System

FDA approves MicroVentions WEB 17 system for treating intracranial wide-neck bifurcation aneurysms.

FDA General

Latest FDA Warning Letter

FDA releases its latest batch of Warning Letters that includes one medical product company Bonagens.

FDA General

FDA/HHS Play Musical Chairs with Chief Counsel Post

In an apparent rebuke of FDA commissioner Stephen Hahn, HHS overrides his choice of who will temporarily lead the Office of Chief Counsel after chief ...

Human Drugs

48 Attorneys General Prod FDA on Opioid Abuse

Attorneys General from 48 states ask FDA commissioner Stephen Hahn to provide a progress report on recent steps the agency has taken to combat the opi...

FDA General

FDA Regulatory Science Report Signals Top Priorities

A new FDA report identifies four regulatory science strategic initiatives for 2021 that includes unleashing the power of data, and increasing choice a...

Federal Register

Comments Sought on Antimicrobials Used in Feed Paper

Federal Register notice: FDA requests comments on a document entitled Potential Approach for Defining Durations of Use for Medically Important Antimic...

Federal Register

Industry Reps Sought for Mammography Panel

Federal Register notice: FDA seels industry organizations interested in participating in the selection of nonvoting industry representatives to serve ...

Federal Register

Info Collection for Fellowship/Traineeship Programs

Federal Register notice: FDA seeks comments on a proposed Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship P...

Human Drugs

FDA Chief Counsel Amin Resigns

FDA chief counsel Stacy Cline Amin resigns after leading the agencys legal shop for over two years.