US FDA Amps Up "Name And Shame" Approach To Thwart Anti-Generic Tactics
New draft guidance says citizen petition abuses will be referred to FTC and publicly called out as attempts to delay ANDA approvals.
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Will CBO Score CREATE Momentum For Generic Bill's Passage?
Strong savings estimate – and brand pharma's need to have pay-fors for its own legislative priorities – could finally get bill allowing generic companies to sue brand sponsors for access to samples.
REMS Abuse Website: All Sizzle, No Steak?
AAM President Davis contends he hasn't seen any evidence showing that reference listed drug access inquiries webpage has changed innovator behavior.
FDA's Generic Policy Initiative Includes Choose-Your-Own-Agenda Meeting
US agency is seeking feedback from interested stakeholders about administrative steps it can take to better promote generic competition; July 18 meeting will involve only presentations from the public.