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Lillis Foundation Asks C. Difficile Treatment Actions

[ Price : $8.95]

The Peggy Lillis C. diff foundation asks FDA to take specific actions to improve the availability of microbiome treatments for C. ...

Histogen Notified of FDA Clinical Hold on IND Trial

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FDA notifies Histogen verbally of a coming clinical hold on its planned Phase 1/2 trial of HST-003.

Rule on Tobacco Product Substantial Equivalence

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Federal Register notice: FDA issues a final rule to provide additional information on the content and format of reports intended t...

GSK Waits for Inspection to Complete Dostarlimab Review

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FDA defers a review action on GlaxoSmithKlines PD-1 drug dostarlimab, indicated for treating endometrial cancer, because it could ...

Report Chronicles Hahns Politicized Career at FDA

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A Vanity Fair special report examines how former FDA commissioner Stephen Hahn became the most politicized commissioner in recent ...

Eitan Medical Upgraded Sapphire Pump Cleared

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FDA clears an Eitan Medical 510(k) for its upgraded Sapphire infusion pump system and software Rev15, which includes pump, adminis...

Flawless Product Launch Helps Commercial Success: Consultants

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L.E.K. consulting says better product launches are a key to profits in drug development over the last 15 years.

Rule on Agency Reviews of Certain Regulations

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Federal Register Final Rule: HHS issues a final rule under the Regulatory Flexibility Act that requires agencies like FDA to publi...

FDA Lifts Hold on Pieris Pharma Clinical Trial

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FDA removes a partial clinical hold on a Pieris Pharmaceuticals Phase 1 study of PRS-343 that was issued while the company conduct...

FDA Advanced Manufacturing Collaboration with NIST

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FDA commissioner Stephen Hahn and senior advisor Colin Rom say a new collaborative effort with the National Institute of Standards...