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Drugmakers seeking certification that their products comply with the European Pharmacopoeia will soon face a two-step process for having their applications approved by the European Directorate for the Quality of Medicines & HealthCare. Read More
An FDA proposal to only allow stool for fecal matter transplants (FMT) from donors known to patients or their physicians has come under heavy fire from critics who argue it will actually make the procedure more risky and shut down stool banks. Read More
Companies designing medical device trials for children can use age as a starting point to categorize the patient population, but other physiological and developmental factors should be taken into consideration as well, an FDA final guidance says. Read More
While manufacturers support a strong pharmacovigilance system to ensure patient safety, the proposed costs are a source of concern, “especially in light of the annual saving for the pharmaceutical industry of 145 million euros (US $201 million) that was anticipated in the 2008 European Commission ‘impact assessment,’” a coalition of five trade groups says. Read More
Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP after a single glass particle was found in just one vial of a lot of the drug, the company said last month. Read More
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