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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include ForYou Inc. and Industry Lab Diagnostic Partners.

Comments Extended on Antimicrobial Animal Drugs

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Federal Register notice: FDA extends the comment period for a 10/13 notice announcing a public meeting and requesting comments on ...

Guide on Animal Drug In-use Stability Studies

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Federal Register notice: FDA makes available a final guidance for industry #242 entitled In-Use Stability Studies and Associated L...

Evaluating Gastric pH-Dependent Drug Interaction Guidance

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FDA makes available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Desi...

NECC Owner Cadden Barred by FDA

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Federal Register notice: FDA issues an order permanently debarring Barry J. Cadden after a conviction in his role as an owner and ...

Drug Approved for Rare Forms of Obesity

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FDA approves a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management in patients six years and olde...

Pilot Program for Novel Drug Development Tools

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FDA launches the Innovative Science and Technology Approaches for New Drugs pilot program for novel drug development tool develope...

Moderna Submits EUA for Covid-19

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Moderna submits an emergency use authorization for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vac...

Profound Medical HDE OKd for Osteoid Osteomas

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FDA approves a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bo...

Former Insys President Debarred by FDA

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Federal Register notice: FDA orders the permanent debarment of Michael L. Babich from providing services in any capacity to a pers...