Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning
Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.
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Generic association advocates enforcement action against companies that use REMS to block generics while PhRMA disputes claims of REMS abuse and citizen petition delay tactics.
FDA Clarifies Scope Of Its Emerging Technology Program
FDA has issued final guidance that clarifies the types of technologies eligible for acceptance into the agency's Emerging Technology Program. FDA also issues internal guidance to explain how reviewers should handle emerging technology applications.
Brand 'Evergreening' Piques FDA Interest, But Solutions Remain Elusive
Agency eager to hear suggestions on the subject, also known as product hopping, but even reform advocates were cautious of stifling meaningful reformulations of products.