In the August 30, 2016, Federal Register, FDA announced it will sponsor a two-day conference titled "FDA Small Business and Industry Assistance Regulatory Education for Industry Fall Conference." The conference is designed for small manufacturers of drugs and/or medical devices who want to learn about FDA's approach to regulating drugs and devices, but anyone involved in the pharmaceutical and/or device industry may attend. Center for Drug Evaluation and Research topics for discussion include manufacturing process validation, interactions with FDA, emerging technology and inspection for new drug applications, and biologic license applications. CDRH topics for discussion include de novo, design controls, and complaints. The meeting will be available via webcast, but there will not be a transcript available following the meeting. The public conference will be held September 27 and 28, 2016.
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