The United States Food and Drug Administration

News & Analysis as of May 21, 2013

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 5/15/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more

Thoughts on Regulatory Constraints of Business Models

by Seth Mailhot | Sheppard Mullin Richter & Hampton LLP on 4/8/2013

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

Vaginal Mesh Damages Against Johnson & Johnson Exceed $11 Million

by Audet & Partners, LLP on 3/5/2013

The first jury verdict against Johnson and Johnson (J&J)’s Ethicon subsidiary has resulted in a powerful statement regarding the pharmaceutical company’s lack of adequate warnings of the health risks posed by the transvaginal...more

IRS Releases Final Rule on Medical Device Tax

by King & Spalding on 12/18/2012

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

by Mao Rong, Gordon B. Schatz, Hugh T. Scogin , Jr., John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 12/17/2012

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

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