Medical Devices
Bipartisan Bill Introduced on Device Cybersecurity
Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) introduce the Protecting and Transforming Cyber Health Care Act that would implement critical cy...
Human Drugs
Catalent Biologics FDA-483 Posted
FDA posts a one-item Form FDA-483 for Catalent Biologics (Bloomington, IN) from a 2020 inspection at the manufacturing site.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 4/1/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 4/1/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Fast Track for Hemophilia A Gene Therapy
FDA grants ASC Therapeutics a fast track designation for ASC618, a second-generation gene therapy for treating hemophilia A patients.
Human Drugs
Merck Pediatric Pneumococcal Vaccine Review Extended
FDA extends by three months its review of a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in infants and children.
Biologics
Y-mAbs Therapeutics Re-files Omburtamab BLA
Y-mAbs Therapeutics resubmits a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma that addresses FDA cited de...
Human Drugs
e-Certificates of Pharmaceutical Product Now Have QR Code
FDA says that it is now issuing electronic Certificates of Pharmaceutical Product that also include a unique Quick Response code to verify authenticit...
Congress Likely to Clarify Contrast Agent Dilemma: Attorney
Epstein Becker & Green attorney James Boiani believes Congress will step in to clarify that contrast agents should be regulated as drugs in the wake o...
