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Drug Surveillance/Epidemiology Office Updates Activities

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CDERs Office of Surveillance and Epidemiology (OSE) discusses new and enhanced activities in postmarketing safety reviews.

Bipartisan Bill Introduced on Device Cybersecurity

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Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduce the Protecting and Transforming Cyber Health Care Act that would i...

Catalent Biologics FDA-483 Posted

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FDA posts a one-item Form FDA-483 for Catalent Biologics (Bloomington, IN) from a 2020 inspection at the manufacturing site.

Fast Track for Hemophilia A Gene Therapy

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FDA grants ASC Therapeutics a fast track designation for ASC618, a second-generation gene therapy for treating hemophilia A patien...

Merck Pediatric Pneumococcal Vaccine Review Extended

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FDA extends by three months its review of a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in i...

Y-mAbs Therapeutics Re-files Omburtamab BLA

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Y-mAbs Therapeutics resubmits a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma that ad...

e-Certificates of Pharmaceutical Product Now Have QR Code

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FDA says that it is now issuing electronic Certificates of Pharmaceutical Product that also include a unique Quick Response code t...

Congress Likely to Clarify Contrast Agent Dilemma: Attorney

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Epstein Becker & Green attorney James Boiani believes Congress will step in to clarify that contrast agents should be regulated as...

FDA Mulls Enforcement Discretion on NAC Products

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FDA says that it is considering exercising enforcement discretion for N-acetyl-L-cysteine-containing products labeled as dietary s...

FDA Approves Knee Cartilage Repair Implant

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FDA approves a CartiHeal PMA for its Agili-C implant, indicated for treating an International Cartilage Repair Society (ICRS) Grad...