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TXT Drug Surveillance/Epidemiology Office Updates Activities [559 Words] [ Price : $8.95]
CDER’s Office of Surveillance and Epidemiology (OSE) discusses new and enhanced activities in postmarketing safety reviews.
04/04/2022
 
 
TXT Bipartisan Bill Introduced on Device Cybersecurity [207 Words] [ Price : $8.95]
Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduce the Protecting and Transforming Cyber Health Care Act that would implement critical cybersecurity requirements for PMA devices.
04/04/2022
 
 
TXT Catalent Biologics FDA-483 Posted [99 Words] [ Price : $8.95]
FDA posts a one-item Form FDA-483 for Catalent Biologics (Bloomington, IN) from a 2020 inspection at the manufacturing site.
04/04/2022
 
 
TXT Fast Track for Hemophilia A Gene Therapy [184 Words] [ Price : $8.95]
FDA grants ASC Therapeutics a fast track designation for ASC618, a second-generation gene therapy for treating hemophilia A patients.
04/01/2022
 
 
TXT Merck Pediatric Pneumococcal Vaccine Review Extended [101 Words] [ Price : $8.95]
FDA extends by three months its review of a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in infants and children.
04/01/2022
 
 
TXT Y-mAbs Therapeutics Re-files Omburtamab BLA [159 Words] [ Price : $8.95]
Y-mAbs Therapeutics resubmits a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma that addresses FDA cited deficiencies in an earlier refuse-to-file letter.
04/01/2022
 
 
TXT e-Certificates of Pharmaceutical Product Now Have QR Code [108 Words] [ Price : $8.95]
FDA says that it is now issuing electronic Certificates of Pharmaceutical Product that also include a unique Quick Response code to verify authenticity.
04/01/2022
 
 
TXT Congress Likely to Clarify Contrast Agent Dilemma: Attorney [537 Words] [ Price : $8.95]
Epstein Becker & Green attorney James Boiani believes Congress will step in to clarify that contrast agents should be regulated as drugs in the wake of a court decision that disrupted the current regulatory construct and leading to some of the products being regulated as devices.
04/01/2022
 
 
TXT FDA Mulls Enforcement Discretion on NAC Products [333 Words] [ Price : $8.95]
FDA says that it is considering exercising enforcement discretion for N-acetyl-L-cysteine-containing products labeled as dietary supplements.
04/01/2022
 
 
TXT FDA Approves Knee Cartilage Repair Implant [163 Words] [ Price : $8.95]
FDA approves a CartiHeal PMA for its Agili-C implant, indicated for treating an International Cartilage Repair Society (ICRS) Grade III or above knee-joint surface lesion.
04/01/2022
 
 
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