In the February 6, 2015, Federal Register, FDA announced it will continue CDER's Regulatory Project Management Site Tours and Regulatory Interaction Program. In this program, small groups of regulatory project managers observe operations of pharmaceutical manufacturing and packaging facilities, laboratories, and regulatory affairs operations. According to FDA, the purpose of the program is not to inspect, assess, judge, or perform a regulatory function but is meant rather to improve mutual understanding and to provide an avenue for open dialogue. Pharmaceutical companies may submit proposed agendas to the Agency by April 7, 2015.
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