We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
President Trump signed a package of legislation reauthorizing the FDA’s user fee agreements for the next five fiscal years — the culmination of over two years of work and negotiations between the federal government and private industry. 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
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
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