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Medical Device Consensus Standards Database Updated

[ Price : $8.95]

FDA updates the CDRH Recognized Consensus Standards database, adding List 59.

FDA Changes Mifepristone REMS

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FDA modifies the mifepristone REMS to remove the in-person dispensing requirement and permit dispensing by certified pharmacies.

FDA Reforms Included in Year-end Omnibus Bill

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In addition to a $226 million boost in FDA spending levels, the year-end omnibus spending bill also includes notable agency reform...

Accord Healthcare Recalls 2 Daptomycin Products

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FDA says Accord Healthcare recalled one lot of daptomycin for injection due to a labeling mix-up.

FDA Approves Acers Olpruva for Urea Cycle Disorders

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FDA approves a resubmitted Acer Therapeutics NDA for its Olpruva to treat some patients with urea cycle disorders.

RoyalVibe Health Refused Inspection: FDA

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FDA warns The Woodlands, TX-based RoyalVibe Health about manufacturing, marketing, and distributing unapproved medical devices tha...

Inspection Issues at Sagents Plattsburgh Facility

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FDA warns Sagent Pharmaceuticals about issues found in an inspection at its Plattsburg, NY-based sterile drug products manufacturi...

FDA Delays PDUFA Action Date for Phathoms Vonoprazan

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FDA says it is delaying the PDUFA action date for Phathoms vonoprazan to treat erosive esophagitis while the company submits addit...

New Alzheimers Drug OK This Week Wont Do Much for Patients: Article

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As FDA prepares a review decision this week on an Eisai and Biogen BLA for Alzheimers drug lecanemab, an article in The Free Press...

REMS Document Format, Content Guidance

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FDA publishes a guidance on the format and content for the REMS document portion of a REMS submission.