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New FDA Off-Label Guide Has Challenges: Lawyers

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Sidley Austin attorneys pull five takeaways, including challenges, from a recent FDA draft guidance on off-label communications be...

FDA Sends 8-item 483 to NATCO Pharma

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FDA issues NATCO Pharma an eight-item Form FDA-483 after concluding an inspection of the firms Telangana, India, manufacturing fac...

API CGMP Deviations at Ali Pharmaceutical

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FDA warns Omaha, NE-based Ali Pharmaceutical Manufacturing about significant CGMP deviations for active pharmaceutical ingredients...

Objectionable Conditions at BTS Research

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FDA warns San Diego, CA-based Samm Solutions about objectionable conditions in its role as the testing facility for two nonclinica...

X4 Pharma NDA Accepted for WHIM Syndrome

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FDA accepts for priority review an X4 Pharmaceuticals NDA for once-daily, oral mavorixafor to treat individuals aged 12 and older ...

FDA OKs Gene Therapy Trial for Heart Disease

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FDA approves a Tenaya Therapeutics IND for the company to begin a Phase 1b trial of TN-401, an adeno-associated virus serotype 9-b...

AdvaMed Points ONCD to Cyber Harmonization

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AdvaMed tells the National Cyber Director about domestic and international efforts involving FDA to harmonize medical device cyber...

Asensus Surgical Recalls Surgical System

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Asensus Surgical recalls its Senhance Surgical System due to the potential for the devices to malfunction.

17 Drugs Not Withdrawn Over Safety/Efficacy: FDA

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Federal Register notice: FDA determines that 17 listed drug products were not withdrawn from sale for safety or efficacy reasons.

Amgens Interchangeable Stelara Biosimilar Approved

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FDA approves an Amgen BLA for Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssens Stelara for multiple inflammat...