Rosen Comments on FDA Commissioner’s Remarks

28 November 2017 Pink Sheet News
Partner David Rosen is quoted in a Pink Sheet article, “Gottlieb’s Complex Generics Remarks Could Signal (Some) Increased Flexibility,” about FDA Commissioner Scott Gottlieb’s remarks on generic copies of products with drug and device constituent parts at an internal FDA event for agency scientists and researchers, where he reinforced the agency’s position to permit a generic product to have certain labeling differences from the branded product if the changes are a result of a permitted design difference.

Rosen said Gottlieb’s remarks appear to signal “a little more flexibility” if changes such as those to a delivery device do not raise clinical efficacy or safety issues. That could include a change from “an open-up, actuate, and click-to-actuate” delivery system to a system that has a “lever that you push or pull,” he said.

“I think that it will really be evaluated on a case-by-case basis to make sure that whatever modifications in or changes in the labeling and in these drug-device combination situations don’t raise safety or clinical efficacy types of issues,” he added.

Related Services

Insights

Hatch Comments on DNC-Related Construction Projects in Milwaukee
14 June 2019
Milwaukee Business Journal
Bernard Quoted on Debt-Relief Settlement with ITT Tech Lender
14 June 2019
Wall Street Journal
Dodd and Daughter Profiled in Wisconsin Golf
13 June 2019
Wisconsin Golf
Brinckerhoff Comments on SCOTUS Ruling in Patent Case
11 June 2019
Intellectual Property Magazine
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call
2019 NDI Executive Exchange
14-15 November 2019
Chicago, IL
Association for Corporate Counsel Annual Meeting 2019
27-30 October 2019
Phoenix, AZ
Foley's Government Contracts Annual Update
16 October 2019
Liviona, MI