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Human Drugs

Evofem Biosciences Re-files NDA for Amphora

Evofem Biosciences resubmits its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH regulator for preven...

Nurse Sentenced for Insys Fentanyl Kickbacks

The Justice Department says an advance practice nurse who worked in a pain clinic was sentenced to three years of probation for accepting kickbacks fr...

Medical Devices

Former FDA Commissioner Frank Young Dies at 88

Former FDA commissioner Frank Young dies at age 88.

Human Drugs

CGMP Violations at Lohxa LLC

FDA warns Lohxa LLC about CGMP violations in its production of finished pharmaceuticals.

Medical Devices

Device-Related Infections Likely Antibiotic-Resistant: Study

A Center for Disease Control and Prevention report says that healthcare-associated infections resulting from medical devices are more likely to be ant...

Human Drugs

CymaBay Stops Seladelpar Studies Over Safety Concerns

CymaBay Therapeutics terminates a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently initiated Phase 2 study...

Federal Register

Device Sterilization Master File Pilot

Federal Register notice: CDRH announces an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization providers to submit a ...

Federal Register

Tobacco Product Modifications Compliance Policy

Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.

Medical Devices

Tusker Medical Ear Infection Tubes Approved

FDA approves a Tusker Medical PMA for the Tubes Under Local Anesthesia System for delivery of tympanostomy tubes (ear tubes) that can be inserted into...

Bipartisan Call to Update 21st Century Cures Act

Reps. Upton and DeGette start a process to improve the 21st Century Cures Act.