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Bill to Improve Diagnostic Test Regulatory Impediments

[ Price : $8.95]

U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) introduce the bipartisan Verifying Accurate, Leading-edge IVCT Developmen...

Hikma Pharma Expanded Recall of Ketorolac Tromethamine

[ Price : $8.95]

Hikma Pharmaceuticals extends a previously announced recall of certain lots of ketorolac tromethamine injection USP 30mg/mL, 1mL f...

Cancer Trial Inclusion Guidance

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FDA publishes a draft guidance on including older adults in oncology clinical trials.

HCT/Ps Regulation Deviations at Reproductive Technologies

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FDA warns Reproductive Technologies about significant deviations from regulations for human cells, tissues, and cellular and tissu...

Exocrine Pancreatic Insufficiency NDA Guide Withdrawn

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Federal Register notice: FDA withdraws its 2006 guidance entitled Exocrine Pancreatic Insufficiency Drug Products Submitting NDAs...

Regulatory Review Period for Ingrezza

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Neurocrine Biosciences Ingr...

Q & A Guide on Deemed to be a License

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Federal Register notice: FDA makes available a guidance entitled The Deemed To Be a License Provision of the BPCI Act: Questions a...

Report Sees More FDA Regulation This Year

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Stericycle says drug and medical device manufacturers will likely see more government regulatory activity from FDA and other agenc...

Drug Metabolite Safety Testing Guidance

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FDA publishes a revised guidance on identifying and characterizing drug metabolites whose nonclinical toxicity needs to be evaluat...

New PDUFA Performance Dashboards Online

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FDA launches new PDUFA performance dashboards in its online performance management program.