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Microdose Radiopharmaceutical Drug Guidance

[ Price : $8.95]

FDA issues a draft guidance on recommended nonclinical studies for microdose radiopharmaceutical diagnostic drugs.

Comment Period Extended on Scheduling Changes to 17 Drugs

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Federal Register notice: FDA extends until 9/20 the comment period for an 8/14 Federal Register notice requesting feedback about a...

TN Man Guilty of Violating FDA Vet. Drug Reg

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Billy K. Groce (Knoxville, TN) pleads guilty to evading FDA veterinary drug regulations.

FDA Accepts for Review 2 Array NDAs for Melanoma Therapy

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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

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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

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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...