Rosen Quoted on Consent Decree

17 July 2013 Inside Health Reform News

Inside Health Reform

Washington, D.C. Partner David Rosen was quoted in an Inside Health Reform article on July 17, 2013 titled, “FDA Legal Action Holds N.J. Compounder to Manufacturing Standards.” The article discusses a recent consent decree of permanent injunction against a drug compounder that FDA previously flagged mandates the pharmacy follow drug manufacturer standards. Mr. Rosen was quoted saying, “They’re holding them to drug manufacturer-style GMPs.” He also noted that drug companies involved in consent decrees sometimes enter a plan to rehab some of their products, whether it be active pharmaceutical ingredients or ingredients in process, but this must be approved by FDA and there is often a bond to ensure it is carried out.

Related Services

Insights

Cryptocurrency in China is like BIG BROTHER in 1984!
20 October 2019
Internet, IT & e-Discovery Blog
California Governor Signs New Telehealth Insurance Law
18 October 2019
Health Care Law Today
Continued Increase in E-Commerce and Online Ordering Changes Landscape of Urban Transportation
17 October 2019
Dashboard Insights
CMS Proposes Revisions to Stark Law
16 October 2019
Health Care Law Today
PATH Summit 2019
18-20 December 2019
Arlington, VA
MedTech Impact Expo & Conference
13-15 December 2019
Las Vegas, NV
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call
BRG Healthcare Leadership Conference
06 December 2019
Washington, D.C.