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Five stakeholders reiterate positions and add new insights from an FDA meeting on progress made toward implementing product identi...[ Price : $8.95]
Stakeholders say they appreciate an FDA draft guidance on when medical device software changes require a new 510(k) and offer prop...[ Price : $8.95]
Three industry stakeholders praise the agreement reached for reauthorization of the Biosimilars User Fee Act.[ Price : $8.95]
FDA says it will no longer require medical evaluations and signed waivers before consumers purchase a hearing aid, and it is consi...[ Price : $8.95]
Federal Register Notice: FDA makes available data extracted from adverse event reports from 2004 to the present for food (includin...[ Price : $8.95]
President-elect Donald Trumps reportedly considers a Silicon Valley venture capital manager to take the helm at FDA.[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Mercks Gardasil 9 (human papillomavirus 9-valent vaccine,...[ Price : $8.95]
Bloomberg News reports that a recent FDA inspection at Suns plant in Halol, India, resulted in a 14-page FDA-483.