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Human Drugs

API Deviations Seen in Fagron Group Inspection

FDA warns St. Paul, MN-based Fagron Group about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Federal Register

Guide on Bladder Cancer Drug Development

Federal Register notice: FDA makes available a final guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment.

Federal Register

Priority Voucher Redeemed for Alexions Ultomiris

Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher AstraZencas sBLA for Ultomiris (ravulizumab-cw...

Medical Devices

GE Carescape Ventilator Recall is Class 1

FDA says the GE Healthcare recall of its Carescape R 860 ventilator due to issues with its backup and replacement backup batteries is Class 1.

Human Drugs

Expert Compounding Pharmacy FDA-483

FDA releases an FDA-483 with six observations from an inspection at Lake Balboa, CA-based Expert Compounding Pharmacy, a producer of non-sterile drugs...

Medical Devices

FDA Updates Digital Health Center of Excellence Activities

FDA updates activities in the Digital Health Center of Excellence.

Human Drugs

OSE Using Artificial Intelligence to Aid Drug Surveillance

CDER Office of Surveillance and Epidemiology staffer Oanh Dang explains how drug safety analysts are using an information visualization platform to ea...

Human Drugs

FDA Announces Pilots on CMC Changes, Hybrid Inspections

FDA announces two new pilot programs that the International Coalition of Medicines Regulatory Authorities (ICMRA), of which the agency is a member, is...

Human Drugs

Gilead Resubmits NDA for HIV Therapy

Gilead Sciences refiles an NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for treating HIV-1 infection in heavily treatm...

Biologics

Panel Recommends Omicron-based Covid Booster Vaccines

FDAs Vaccines and Related Biological Products Advisory Committee votes 19 to 2 to recommend that the SARS-CoV-2 strain composition of Covid-19 vaccine...