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The FDA published new product-specific draft guidances for establishing bioequivalence in 20 drugs and combinations. The agency also revised draft guidances for 12 more substances. Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More
The products include HIV antiretroviral therapies and combinations, a treatment for major depressive disorder and a chemotherapy approved in non-small cell lung cancer. Read More
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine. Read More
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials, as part of an agency “innovation initiative” announced July 7 by Commissioner Scott Gottlieb. Read More
The project will focus on modernizing the agency’s regulatory processes and reducing the time, cost and uncertainty of bringing a product to market. Read More
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials — as well as establish a new framework for regenerative medicine this fall — as part of an agency “innovation initiative” announced Friday by Commissioner Scott Gottlieb. Read More
The decision comes after a review by a data monitoring committee that found more deaths were observed in the Keytruda arms of two Phase III studies. Read More