Stakeholders Offer Some Hatch-Waxman Creativity, Highlight Limits Of FDA Action
Other proposals were broad in nature, and did not provide the agency with specific mechanisms to consider.
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REMS Barriers: US FDA Takes 'Foundational Step' To Improve Generic Access
Generic firms might be able to purchase branded drugs for bioequivalence studies from Europe under concepts that FDA is considering. Commissioner Gottlieb says FDA may allow generic firms to seek wavier of shared REMS to avoid protracted negotiations.
Generic Firms Want Looser Bioequivalence, But Change May Be Difficult For FDA
Sponsors contend that changes to bioequivalence guidances in the middle of a review cycle have delayed approvals; FDA says rule changes might be difficult because of existing regulations.
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.