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new generic drugs

FDA acts to boost Rx drug competition

FDA acts to boost Rx drug competition

WASHINGTON — The Food and Drug Administration today announced two new 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

AAM: REMS abuse trips up new generics

AAM: REMS abuse trips up new generics

The Association for Accessible Medicines (AAM) said a new report shows that abuse of the Food and Drug Administration’s Risk Evaluation Mitigation Strategies (REMS) safety program is hampering the market entry of new generic drugs. This week, AAM said a report by Alex Brill, CEO of economic policy consultancy Matrix Global Advisors, titled “REMS and