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FDA Recognizes A2LA for ASCA Pilot

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FDA recognizes A2LA to assess testing laboratories for the Accreditation Scheme for Conformity Assessment pilot program.

After FDA Meeting, Minerva Continuing Roluperidone Development

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Minerva Neurosciences says it believes it can address negative FDA comments about two roluperidone studies through published regul...

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.

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...

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...