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The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More
The European Medicines Agency is encouraging global regulators to collaborate on life science initiatives after a review of international projects found that several countries pursue common goals without sharing resources or information. Read More
The Yangzhou Hengyuan Daily Chemical Plastic Co. received a warning letter after the FDA found that one of its drugs was missing the active ingredient and that the company was not testing finished batches of drug products. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More
British drugmaker GlaxoSmithKline will pay $20 million to settle the Security and Exchange Commission’s charges that the company bribed healthcare professionals to boost drug sales in China. Read More
Novartis is closing several of its research operations in Switzerland and China and cutting 175 jobs in an effort to centralize control of its drug discovery programs and contain costs. Read More
The FDA is revising the list of drug products that have been banned or removed from the market for safety or effectiveness reasons and so cannot be used in compounding. Read More
