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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
Members of the U.S. House of Representatives are asking the HHS Inspector General to investigate whether a drug industry-funded organization improperly influenced the FDA’s approval of pain drugs such as Zogenix’s Zohydro ER. 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