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FDA General

HHS Secretary Price Resigns Amid Chartered Aircraft Scandal

HHS secretary Tom Price resigns amid a furor over his use of expensive private chartered aircraft for government travel.

Human Drugs

Divis Laboratories Inspection Observations

FDA releases the FDA-483 containing six observations from an inspection at Indias Divis Laboratories.

Human Drugs

FDA Issues Emerging Tech Application Guidance

FDA finalizes a guidance to help drug companies wanting to participate in a program to include emerging technology in specified regulatory submissions...

Federal Register

FDA Seeks Non-voting Members for Device Advisory Panels

Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of nonvoting industry representativ...

Medical Devices

FDA Safety Alert on Endovascular Graft Systems Leaks

FDA alerts vascular surgeons about Type IIIa and IIIb endoleaks with the use of endovascular graft systems for aneurysm repair procedures that treat a...

Human Drugs

Lilly Gains Approval for Verzenio for Breast Cancer

FDA approves an Eli Lilly NDA for Verzenio (abemaciclib) for treating adult patients who have hormone receptor-positive, human epidermal growth factor...

Medical Devices

FDA Clears Expanding Orthopedics Cage

FDA clears an Expanding Orthopedics 510(k) for the FLXfit 15 3D Expandable Cage System for restoring lumbar lordosis while controlling sagittal and co...

Human Drugs

FDA Extending REMS to IR Opioids

FDA commissioner Scott Gottlieb outlines additional steps the agency is taking to try to cut overall exposure to opioids.

Human Drugs

Toxicity Testing, Labeling Guidance Out

FDA publishes a draft guidance on reproductive toxicity assessments for anti-cancer drugs.

Human Drugs

ANDA Deficiency Communication MAPP

CDER issues a MAPP for ANDA filing reviewers on the procedure for communicating with applicants about submissions that contain minor technical deficie...