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Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. The selection of 10 metrics could present a significant challenge for industry, however, which has called for collecting only four metrics. Read More
The FDA warned Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel, but the company says its labeling can back up the claims. Read More
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products. Read More
The FDA has issued guidance on using social media for approved products, but the agency has been markedly silent on how drugmakers can use Facebook, Twitter and other platforms for drug development, an expert said. Read More
Impax has agreed to pay shareholders $8 million to end a class action lawsuit alleging the brand and generics maker deliberately withheld the extent of its manufacturing practice violation problems. Read More
The FDA launched a new data dashboard Thursday it says provides a more user-friendly way for manufacturers to obtain inspection and recall data. Read More
Manufacturers that sell drugs in the European Union will soon have to make publicly available clinical trial data supporting approval of those products, under a landmark transparency policy adopted yesterday by the European Medicines Agency. Read More
Eli Lilly has given up on its lupus drug candidate tabalumab after researchers determined the efficacy data from two Phase III studies were not strong enough to support a regulatory submission. Read More
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products. Read More