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Article

Venable LLP | USA | 21 Oct 2016

FDA Final Rule Implementing and Amending Regulations regarding Title XI of Medicare Prescription Drug, Improvement, and Modernization Act (“MMA”) of 2003

On October 6, 2016, FDA published a Final Rule in the Federal Register to implement and amend certain regulations regarding the MMA. These changes

Article

Gowling WLG | USA | 9 Feb 2009

FDA requires increased disclosure of bioequivalence studies for ANDA applicants

Effective July 15, 2009, the U.S. Food and Drug Administration (FDA) will require applicants of an abbreviated new drug application (ANDA) to submit all data from bioequivalence studies that have been conducted on the particular drug formulation submitted for approval.

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