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Novartis was the only company that volunteered as a host for FDA’s Regulatory Project Management Site Tours and Regulatory Interaction Program as of the original April 11 deadline provided in the February 9 Federal Register announcement. Novartis invited FDA to visit its tox lab and cell/gene therapy (CGT) manufacturing facility on its East Hanover, New Jersey campus. [See IPQ March 29, 2015 for a review of Novartis’ advancing CGT development program.] The program is part of CDER’s effort to enhance review efficiency and quality by providing staff with a better understanding of the pharmaceutical industry and its operations. “Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a reg- ulatory function,” the register notice stated, “but is meant rather to improve mutual understanding and provide an avenue for open dialogue.” CDER is continuing to invite other firms to participate.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
