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Makary Details DTC Enforcement Crackdown on Podcast

[ Price : $8.95]

FDA commissioner Marty Makary addresses during a podcast the agencys significant shift in enforcement policy directed at pha...

FDA Still Finding Issues at Nephron Pharmaceuticals

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A South Carolina newspaper reports that the latest FDA inspection at Nephron Pharmaceuticals found the company still has significa...

Moderna Quits CMV Vaccine After Phase 3 Failure

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Moderna stops the development of its congenital cytomegalovirus vaccine after it failed to meet the primary endpoint in a large Ph...

3rd Patient-Focused Drug Development Guidance

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FDA publishes the third in a series of guidances on aspects of collecting patient experience data to be used in medical product de...

Major Staff Losses at CDER and CBER Amid Shake-up

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FDA releases hiring data showing steep declines in staffing at CDER and CBER.

CGMP Violations Seen in BRS Services Inspection

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FDA warns St. Louis, MO-based BRS Analytical Services about CGMP violations in its production of finished drugs.

GSK and Speros Antibiotic Positive Phase 3 Results

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GSK and Spero Therapeutics report positive Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated u...

FDA Strengthens Tranexamic Acid Warning

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FDA says it is strengthening labeling for tranexamic acid injection products to clarify that it is only to be administered intrave...

FDA Contracts with ISMP on Medication Errors

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FDA contracts with the Institute for Safe Medication Practices for services to strengthen its ability to identify and reduce the r...

Workshop on Patch Tests for Allergic Contact Dermatitis

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FDA hosts a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic...