AAM, PhRMA Renew Rivalry In Hatch-Waxman Public Comments
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.
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CREATES Act gets a hearing, but Judiciary committee members spend much of their time asking questions about basic concepts of FDA review.
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.
Brands Push Back Against REMS Reform, Call Problem Small With Burdensome Fixes
BIO cautioned that its members may have difficulties meeting the purchase orders of product for generic sponsors, while PhRMA contended legislation is not necessary.