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Dr. D. C. Tayal, Ingenious e Brain Solutions, explores the implementation of US FDA’S new rule pertaining to laws that govern the submission and approval of AND A and 505b (2) applications, which maintains a balance between the generic drugs approval and acknowledging the innovation presented by brand name drugs.

The US Food and Drug Administration (FDA) has introduced a significant change in the arena of pharmaceutical patents through its decision to revamp the rules pertaining to Medicare Prescription Drug, Improvement, and Modernization Act (MMA), 2003. The new regulations – referred to as final rule – were published in the federal register on October 6, 2016, under the title “Abbreviated New Drug Applications and 505(b)(2) Applications”. These revised rules have been effective from December 5, 2016. The final rule published by FDA is an implementation of the part of the rules it proposed in February 2015.

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