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Medical Devices

FDA Asked to Stop Some Dental Amalgam Use

The Campaign for Mercury Free Dentistry petitions FDA to warn dentists and their patients that amalgam should not be used in children under age 15, pr...

Human Drugs

FDA Hiring Freeze Lifted; Trump Wants Plan to Cut Costs

President Trump lifts his January-ordered hiring freeze affecting FDA and other agencies, and instead he has ordered agencies to take immediate action...

Human Drugs

FDA Approves Ingrezza for Tardive Dyskinesia

FDA approves a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia, a neurological disorder charact...

Human Drugs

WHO Looking for Alternate Levonorgestrel API Sources

The WHO says it is trying to find an alternate levonorgestrel API supplier since the current supplier is now under an FDA import alert.

Human Drugs

DoJ Enforcing cGMP Under False Claims Act

Attorney Anne Walsh questions the creative Justice Department enforcement action against Baxter using a False Claims Act settlement to resolve cGMP is...

Medical Devices

FDA Clears Alere Diagnostic Analyzer

FDA clears an Alere 510(k) for the Alere Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings.

FDA General

FDA, Emulate CRADA on Organs-on Chips Technology

FDA and Emulate enter into a Cooperative Research and Development Agreement to evaluate and qualify the use of Emulates Organs-on-Chips technology as ...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that cite Indoco Remedies and Mylan Pharmaceuticals.

Human Drugs

BPCIA Has Protective Order Negotiating Room: Attorneys

McCullough Robertson attorneys examine the default provisions in the BPCIA patent dance and how they can be negotiated to set prosecution and regulato...

Human Drugs

CGMP Violations at Indias Indoco Remedies

FDA warns Indias Indoco Remedies about repeat CGMP violations in the production of finished pharmaceuticals.