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Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance By Zachary Brennan - Published 20 December 2017

Drugmakers Sanofi and Teva, alongside industry groups AAM and the Bulk Pharmaceuticals Task Force, offered their comments earlier this month on new draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: ANDA formal meetings, FDA draft guidance, SOCMA, Teva, Sanofi