FDA tackles drug competition to improve patient access

FDA

27 June 2017 - Agency takes important steps under new Drug Competition Action Plan.

Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.

These actions are among the first taken under the agency’s Drug Competition Action Plan, announced by FDA Commissioner Scott Gottlieb in late May.

Read FDA press release

Michael Wonder

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Michael Wonder