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FDA General

GAO to Probe Trump Administration Political Interference

The Government Accountability Office agrees to conduct an investigation of the Trump Administrations alleged political interference at FDA and the CDC...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/16/2020.

Federal Register

Patent Listing in Orange Book Comments Extended

Federal Register notice: FDA reopens the comment period for a 6/1 notice entitled Listing of Patent Information in the Orange Book; Establishment of a...

Federal Register

Comments Sought on Covid-19 Guidances

Federal Register notice: FDA makes available three guidance documents related to the Covid19 public health emergency that are subject to comments.

Federal Register

Device Biotin Interference Testing Guidance

FDA posts a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.

FDA General

Two Ex-Supplement Marketers Sentenced to Prison

The northern Texas federal court sentences two former dietary supplement company executives to prison and orders two companies to pay a combined $10.7...

Biologics

Pfizer CEO Predicts Covid Vaccine EUA Filing in November

Pfizer CEO Albert Bourla says the company and its development partner BioNTech could file an emergency use authorization for their Covid-19 vaccine du...

FDA General

FDA Exploring Live Video Inspections During Covid

FDA associate commissioner for regulatory affairs Judith McMeekin says the agency is evaluating whether it can use live or recorded video to conduct m...

Federal Register

Quality Management Maturity Pilot for APIs

Federal Register notice: FDA announces a Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for foreign facilities manufa...

Medical Devices

CDRH Pioritized Guidance Listing for FY 2021

CDRH posts a list of prioritized guidance documents that it intends to publish during fiscal year 2021.