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