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FDA Accepts for Review 2 Array NDAs for Melanoma Therapy

[ Price : $8.95]

FDA accepts for review two Array BioPharma NDAs to support use of the combination of binimetinib 45 mg twice daily and encorafenib...

Woodcock to Testify at Hearing on Improving OTC Monograph Process

[ Price : $8.95]

CDER director Janet Woodcock testifies before a 9/13 House Energy and Commerce Subcommittee on Health about Modernizing FDAs Regul...

FDA Guide on Device Study Reporting of Age, Race Data

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Federal Register notice: FDA makes available a guidance entitled Evaluation and Reporting of Age, Race, and Ethnicity Data in Medi...

Dont Move Imodium from OTC to Rx: CHPA

[ Price : $8.95]

The Consumer Healthcare Products Association says there is no need for FDA to approve a change for Imodium from over-the-counter t...

Allergan Transfers Restasis Patents to Native American Tribe

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Allergan transfers Restasis patents to a Native American tribe to shield them from review by the U.S. Patent Trial and Appeal Boar...

Patch Test for Allergic Contact Dermatitis Approved

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FDA approves a SmartPractice PMA for its TRUE Test ready-to-use patch test panels for pediatric patients as young as six years of ...

FDA Meeting Orphan Drug Goals: Gottlieb

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FDA commissioner Scott Gottlieb says the agency has eliminated a backlog of orphan drug designation applications that were more th...

Gilead Asks 9th Circuit to Rehear HIV Drug Case

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Gilead, supported by the Washington Legal Foundation, asks the 9th Circuit Court of Appeals to rehear a False Claims Act case invo...

PMA Critical to Quality Pilot Program

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Federal Register notice: FDA announces a Premarket Approval Application Critical to Quality pilot program.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Dynavision International and HomeoCare Laboratories.