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One-Time Marketing Status Reports Due in February, FDA Says By Zachary Brennan - Published 03 January 2018

The US Food and Drug Administration (FDA) is calling on all new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: marketing status, user fee, FDARA, FDA status reports