On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance addresses conditions under which the FDA does not intend to take action for violations of 505, 502(f)(1) and 501(a)(2)(B) of … Continue Reading
The February 2014 decision (discussed in an earlier blog post) in which the U.S. Court of Appeals for the Fourth Circuit dismissed the False Claims Act (FCA) charges brought in United States ex rel. Rostholder v. Omnicare, Inc. was confirmed on October 6, 2014, when the U.S. Supreme Court declined to review the Rostholder decision. … Continue Reading
Reed Smith Partner Larry Sher authored a post on the Drug and Device Law Blog about a recent decision in which the U.S. Court of Appeals for the Fourth Circuit affirmed the dismissal of a False Claims Act (“FCA”) case brought against Omnicare, United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, 2014 WL 661351 … Continue Reading
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.
Some important developments during January include:
- Outline of China's Nursing Development Plan from 2011 to 2015
- Promulgation of Eight Recommended Medical Product Industry Standards
- Strengthening Implementation of 2010 GMP Amendment
- Circulation of the 12th Five-Year Plan for Medical Device Technology Industry… Continue Reading