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Cancer R&D Study Draws Advocate Fire

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Industry advocates challenge conclusions in a JAMA Internal Medicine analysis of the cost and potential revenue involved in develo...

Draft PQ/CMC Standardization Concerns Raised

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Drug companies say FDA should do more work on its draft document on standardization of pharmaceutical quality and chemistry, manuf...

FDA Panel Backs Warning on Gadolinium-based Contrast Agents

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FDAs Medical Imaging Drugs Advisory Committee votes to recommend a warning about gadolinium retention for gadolinium-based contras...

Woodcock Supports Reforms to OTC Monograph Program

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CDER director Janet Woodcock tells a House Energy and Commerce Health Subcommittee hearing that the current monograph system for o...

Cardio Drug Approval Rates Drop 52% in 30 Years: Analysis

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A Tufts Center for the Study of Drug Development analysis finds that the FDA approval rate for cardiovascular drugs has dropped 52...

CGMP Violations at HomeoCare Laboratories

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FDA warns HomeoCare Laboratories about CGMP violations in its production of three misbranded homeopathic drugs.

Dynavision D2 Adulterated and Misbranded: FDA

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FDA warns Dynavision that its D2 device is adulterated and misbranded and fails to conform to Quality System regulation requiremen...

Microdose Radiopharmaceutical Drug Guidance

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FDA issues a draft guidance on recommended nonclinical studies for microdose radiopharmaceutical diagnostic drugs.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