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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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More