Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz.

Reed Smith’s China Life Sciences and Health Industry Client 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 October include:

• China Becoming a Healthcare R&D Hub
• Imported Drugs to Go on China's Electronic Monitoring Network
• Guangxi to Build Pharmaceuticals as a Pillar Industry
• China to Set Up Database for Organ Transplants
• Private Medical Care Gets Boost
• State Council Issues the 12th FYP for Public Health Services Development

To read the full briefing by Reed Smith China team members, click here.

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This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz.

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

To read the full briefing by Reed Smith China team members, click here.
 

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This post was written by Frederick H. Branding, R.Ph., JD and Kevin M. Madagan.

Numerous signals by the Food and Drug Administration (“FDA”) in recent weeks, including statements made by Dr. Margaret A. Hamburg, the recently appointed FDA Commissioner, show that the agency intends to toughen enforcement in several areas. These signals should be taken seriously. An “awakened” FDA will be funded with additional monies promised for FDA’s budget and with funding proposed through legislation such as The Drug and Device Accountability Act of 2009 (S. 882). As a result, firms that manufacture, import, and distribute FDA-regulated products can anticipate being visited more often, and probably more critically, than in the past. This, in turn, will force a company to handle additional Inspectional Observations (FDA 483s), Warning Letters, and reinforcement actions.

This article discusses two areas in which FDA has begun to focus – supply chains and imports, in particular supply chain management and safety, and increased foreign and domestic import inspections. Included in the discussion are suggestions companies may wish to consider in preparing for increased regulatory scrutiny.

To read the full alert, click here.

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