Archive for September 2022

German drug manufacturer System Kosmetik has drawn an FDA warning letter for lacking manufacturing process validation and other deficiencies observed during an FDA inspection of its facility in Bavaria in February. Source: Drug Industry Daily

It’s been a long time coming, but the FDA has finally published a pair of proposed rules designed to sync the agency’s institutional review board (IRB) and informed consent requirements with the Common Rule, the regulation used by most federal agencies to guide human subjects research. Source: Drug Industry Daily

Verdiperstat, Biohaven’s investigational drug for amyotrophic lateral sclerosis (ALS), didn’t pass its phase 3 muster, failing to slow progression of the fatal muscle-wasting disease. Source: Drug Industry Daily

One day before the end of the fiscal year, the U.S. Senate passed a continuing resolution (CR) with FDA user fee authorization attached to it, moving closer to an 11th-hour funding of about half of the agency’s budget for the next five-years. Source: Drug Industry Daily

The Center for Biologics Evaluation and Research’s (CBER) Office of Tissues and Advanced Therapies has been renamed the Office of Therapeutic Products (OTP). Source: Drug Industry Daily

The FDA issued a warning letter to Zhejiang Tianyu Pharmaceutical for significant deviations from current good manufacturing practices (cGMP), including impurities and lax cleaning of equipment. Source: Drug Industry Daily

Biogen and developmental partner Esai are touting positive phase 3 data for their antiamyloid antibody lecanemab, saying the drug slowed cognitive decline by 27 percent among 1,795 patients with early Alzheimer’s disease. Source: Drug Industry Daily

Multiple comments on the FDA’s efforts to provide guidance on how sponsors can develop patient-focused clinical outcome assessments (COA) for regulatory decision-making called for more clarity on one of the four types of COA — patient reported outcomes (PRO) — and on using digital health technology (DHT) for COA data. Source: Drug Industry Daily

Following up on a provision of the CARES (Coronavirus Aid, Relief and Economic Security) Act on the regulation of over-the-counter (OTC) monograph drugs, the FDA has issued draft guidance on how submitters should send OTC monographs requests (OMOR) electronically prior to marketing a drug. Source: Drug Industry Daily

The FDA has placed a partial clinical hold on Avidity Biosciences’ phase 1/2 MARINA study after one person treated with AOC 1001, an investigational gene therapy for myotonic dystrophy type 1 (DM1), experienced a serious adverse event. Source: Drug Industry Daily