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Prolixin Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Prolixin (fluphenazine hydrochloride) tablets, 1 mg (mg), 2.5 mg, 5 mg, and 10 mg, we...

Cancer Groups Offer Oncology Trial Guidance

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The American Society of Clinical Oncology and the Friends of Cancer Research jointly give FDA draft guidance language to expand el...

FDA to Study Ad Disclosures

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FDA says it wants to do research on how well healthcare professionals and consumers can use direct-to-consumer print ad prescripti...

FDA Extends 1 GUDID Compliance Date

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FDA extends to 9/24/19 the compliance date for submission requirements of a device constituent of co-packaged combination products...

Workshop on Skin Safety Testing with Topical Drugs

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FDA announces a 9/10 public workshop entitled Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and...

Aidoc Artificial Intelligence Cleared for Brain Hemorrhages

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FDA clears an Aidoc artificial intelligence solution for radiologists to flag acute intracranial hemorrhage cases in head computed...

Elevair Emphysema Device Not Approvable: FDA

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FDA issues a not approvable letter to PneumRx for its PMA application for Elevair Endobronchial Coil System for treating people wi...

Committee Backs Parateks Omadacycline

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The FDA Antimicrobial Drug Advisory Committee tells the agency that Parateks omadacycline is safe and effective for two indication...

4 NDA Approvals Withdrawn by FDA

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Federal Register notice: FDA withdraws approval of four NDAs from multiple applicants after they told the agency that the products...

Guide on Drug Product Elemental Impurities

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Federal Register notice: FDA makes available a final guidance entitled Elemental Impurities in Drug Products.