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With an eye toward improving product quality, the FDA is inviting drugmakers to join a program to evaluate emerging manufacturing technology. Read More
The FDA has issued a proposed rule harmonizing regulations for prescription and OTC fixed dose combination products, along with co-packaged drugs and combinations of active ingredients under consideration for inclusion in an OTC monograph. Read More
Another Indian drugmaker is in hot water with the FDA, with Sun Pharma’s Halol, Gujarat, facility earning a warning letter for a lack of sterility assurance and validation of the sterility system. Read More
A number of drugmakers got good news from the European Medicines Agency’s Committee for Medicinal Products for Human Use, including two companies looking to have their lung cancer candidates approved in Europe. Read More
The FDA’s first public meeting on the 2017 reauthorization of the Biosimilars User Fee Act brought calls for increased transparency in terms of how the agency regulates biosimilars and a rethinking of how these products will be named. Read More
President Barack Obama signed into law on Friday the fiscal 2016 omnibus spending bill, which contains $4.68 billion in total funding for the FDA. Read More
Turing Pharmaceuticals CEO Martin Shkreli has been indicted on seven counts of securities and wire fraud for alleged conduct at several of his previous companies. Read More
Drugmakers that have not started complying with worldwide track and trace regulations are behind the eight ball, as most companies only allow for two to three years for implementation, a supply chain expert warns. Read More