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FDA Final Guidance on Postmarketing Safety Reporting for Combination Products

USA - July 29 2019 On July 22, 2019, FDA issued final guidance on postmarketing safety reporting (“PMSR”) for combination products. The guidance focuses on ways to...

Nicholas J Doyle.

Securing and Maintaining a Strong Patent Portfolio for Pharmaceuticals

USA - May 28 2019 Discovering, developing, and obtaining market approval for a new pharmaceutical product is a long, complex, and expensive process. By securing and...

M. David Weingarten.

FDA Final Guidance on Submitting an ANDA or a 505(b)(2)

USA - May 14 2019 On May 9, 2019, FDA issued final guidance titled, “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” FDA intends the guidance to...

Megan L. Meyers.

FDA Commissioner’s Statement on Plans for the Orange Book

USA - March 9 2019 After dropping hints in recent months that he intended to use creative policy efforts to promote competition in the American pharmaceutical industry...

Ryan P. O’Quinn, Ph.D..

FDA Commissioner Statement about the Orange Book

USA - February 7 2019 On January 30, 2019, FDA Commissioner Scott Gottlieb issued a statement on FDA’s efforts to enhance the utility of the Orange Book to Foster drug...

Ryan P. O’Quinn, Ph.D..