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Human Drugs

FDA Needs Better Workforce Planning: GAO

A new Government Accountability Office report says FDA needs better planning for its recruitment and retention of medical product staff.

Federal Register

Public Hearing on Carbadox Carcinogenic Concern

Federal Register notice: FDA announces a 3/10 virtual public hearing on scientific data and information related to the residue of carcinogenic concern...

Human Drugs

4 Observations in SSM Health Care Inspection

FDA releases the FDA-483 with four observations from an inspection at Fenton, MO-based SSM St. Clare Health Center.

Medical Devices

Updated Safety Info on Endologix Grafts

FDA updates its 12/2020 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and the risks as...

Medical Devices

Mentor MemoryGel Boost Breast Implant OKd

FDA approves Mentors MemoryGel Boost Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breas...

Human Drugs

FDA Covid Drug Limits Criticized

A physician and a trade association executive say FDA requirements for using Covid-19 antiviral drugs will work against people who could benefit from ...

Human Drugs

FDA Clinical Hold on Denali Alzheimers Drug

FDA puts a clinical hold on Denali Therapeutics DNL919 IND for Alzheimers.

Medical Devices

Initial Device Safety Summaries Out

FDA releases nine safety summaries for materials that are commonly used in implantable medical devices.

Human Drugs

Companies Seek Expanded Sotrovimab EUA

GlaxoSmithKline and Vir ask FDA to allow intramuscular administration of their Covid-19 monoclonal antibody treatment sotrovimab.

Human Drugs

Clinical Trial Company Owner Pleads Guilty

The Justice Department says Miamis Olga Torres pleaded guilty to obstructing an FDA inspection at the Florida clinical research site she co-owned.