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Sens. Elizabeth Warren (D-Mass.) and Shelley Moore Capito (R-W.Va.) urged FDA Commissioner Scott Gottlieb to task the agency’s opioid policy steering committee with promoting “partial fill” policies to limit the number of unused pills in circulation. Read More
The committee’s report will assess the quality, safety and efficacy of the product, as well as examine the risk-benefit balance based on intended populations and markets. Read More
The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported. Read More
Biocon said it plans to re-submit applications for European approval of two cancer-treatment biosimilars as soon as it corrects serious GMP deficiencies found at a Bangalore manufacturing plant. The company said it intends to fix the problems by Sept. 30. Read More
The FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals. Read More
Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More
The FDA has agreed to fully share information from its inspections of drug manufacturers with its European Union counterparts, including for the first time trade secrets, the agencies announced. Read More
The FDA cited two compounders and two drugmakers for failure to maintain aseptic conditions and for other shortcomings, as reflected in Form 483 inspection reports. Read More