Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Food & Health Care Industries.
Some important developments during June include:
- Chinese drug company to build production and training center in U.S.
- Drug company challenged for environmental contamination in China
- China's national biomedical plan to be released soon
- Issuance of administrative measures for device recalls
- Designation of four professional associations to examine Class III medical technology
- Extension of Drug GMP certificates
- Recall of an antibiotic… Continue Reading
On May 26, 2011, Vermont Governor Peter Shumlin signed into law Senate Bill 104 ("S.104"), significantly modifying Vermont law banning the provision by manufacturers of gifts to health care providers and requiring disclosure of certain allowable expenditures and gifts to health care providers (18 V.S.A. § 4631a and 18 V.S.A. § 4632). S.104 follows amendments made to the Vermont gift ban and disclosure law enacted just last year. This Client Alert includes a summary of the modifications pursuant to S.104. Except as otherwise noted, the changes are effective July 1, 2011.… Continue Reading
The Federal Communications Commission (FCC) just announced that, as part of its implementation of the recently released National Broadband Plan and the Plan's recommendation to use the power of broadband to improve healthcare, the FCC and the Food and Drug Administration (FDA) are going to be holding a public meeting on July 26 and 27, 2010, to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices. The meeting is formally entitled: "Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes." The purpose of this meeting is, among other things, to discuss ways to promote investment and innovation in health technology by streamlining government processes.
To help develop an agenda for this important meeting, the FDA and the FCC are seeking input from, among others, the medical and device manufacturing industries, practitioners, and other stakeholders and users of medical technology on a number of questions regarding regulatory challenges and safety of patients and other users of medical devices that include radio elements and of systems that can be tied into broadband communications networks.… Continue Reading