Partner David Rosen is quoted in a Modern Healthcare article, “FDA to pave clearer path for generic drugs,” about new agency guidance that aims to make it easier for generic pharmaceutical developers to plan how they can copy complex drugs.
While the new guidance provides some flexibility in evaluating drugs that face roadblocks to market, Rosen said, there is some gray area in defining how much generics can vary. “How much generic drugs can vary and not affect the clinical effect or safety profile remains to be seen,” he said. “We have to make sure we do things that are in the best interest of the patients.”
While the new guidance provides some flexibility in evaluating drugs that face roadblocks to market, Rosen said, there is some gray area in defining how much generics can vary. “How much generic drugs can vary and not affect the clinical effect or safety profile remains to be seen,” he said. “We have to make sure we do things that are in the best interest of the patients.”
People
Related News
27 August 2024
In the News
Samuel Goldstick Assesses Data Privacy Challenges for Automakers
Foley & Lardner LLP partner Samuel Goldstick underscored how disclosure can help automakers reduce legal risk in the Automotive Dive article, "Automakers face growing data privacy challenges, experts say."
26 August 2024
In the News
Judith Waltz Quoted on Inflation Reduction Act, Pharma Impact
Foley & Lardner LLP partner Judith Waltz is quoted in the PharmaVoice article, "Pharmas’ IRA court losses mount. They keep pursuing them."
20 August 2024
In the News
Kevin Hyde Featured in Q&A on Jacksonville Legal Market – 'The outlook is good'
Foley & Lardner LLP partner Kevin Hyde is featured in a Capital Analytics Associates Q&A on the major achievements of Foley's Jacksonville office, key trends in the legal market, and the firm's commitment to its talent and client service.