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The European Medicines Agency (EMA) on Mar. 11 launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014. Read More
Influenza vaccine manufacturers in the EU must file strain variation applications for next year’s flu season with the European Medicines Agency (EMA) by June 16. Read More
A European Medicines Agency working group is recommending revisions to a guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins to account for differences between large complex and small, simple-structured proteins and other critical issues. Read More
The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches. Read More
The FDA is asking sponsors of ANDAs, BLAs and NDAs to justify the amount of excess medication they plan to pack in vials and ampules of injectable drug products. Read More
The FDA said Thursday that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet. Read More
House GOP lawmakers are concerned that the FDA has expanded rapidly under President Barack Obama’s administration and want the agency to justify the additional 8 percent budget increase the president has proposed for it in 2015. Read More
The UK’s health cost-benefit watchdog is developing new “burden of illness” and “societal impact” measurements to use when assessing new drugs for government reimbursement. Read More
The European Medicines Agency plans to move forward with a controversial clinical trial transparency plan, but with new added redaction features to remove trial data that could allow companies to steal commercially confidential information. Read More
Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More
GlaxoSmithKline has withdrawn a marketing application for a cancer drug combination in Europe, saying it will wait for results from two ongoing Phase III trials before resubmitting the application. Read More