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When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
Purdue Pharma wants immediate-release opioids subjected to the restrictive labeling and postmarketing studies now required for extended release and long-acting (ER/LA) products such as the company’s flagship drug OxyContin. Read More
The FDA and European Medicines Agency (EMA) have launched a new information-sharing initiative they hope will coordinate and speed international responses to drug safety problems. Read More
Dynavax is withdrawing a European marketing authorization application for the Heplisav hepatitis B vaccine over concerns with adequate safety information. Read More
Chelsea Therapeutics’ orphan blood-pressure drug Northera won FDA approval Tuesday, following a rocky review path that included two advisory panel nods and a complete response letter. Read More
Sponsors should prepare to submit information on their television marketing operations in an updated Module 1 electronic common technical documents (eCTD) format before the end of the year. Read More
BI subsidiary Ben Venue is recalling a lot of acetylcysteine 10 percent USP, after a single glass particle was seen in a single vial of the drug. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, India’s Central Drugs Standard Control Organization (CDSCO) said Thursday. Read More
In the wake of a rash of infant deaths related to GMP-certified hepatitis B vaccines, China is renewing its push to have makers of vaccines, blood products and sterile injectables obtain a revised good manufacturing practice certificate. Read More