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 Areta L. Kupchyk, Kevin M. Madagan and Erin A. Janssen.

On October 19, 2011 the Food and Drug Administration (“FDA”) published a proposed rule in the Federal Register that would amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act (the “Proposed Rule”). Comments to the Proposed Rule should be submitted no later than January 17, 2012. This client alert summarizes these proposed changes and discusses the potential impact of the Proposed Rule on the drug, biological product, and biotechnology industry.

To read the full alert, click here.

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This post was written by Jay Yan, Mao Rong, Zack Dong, Zhao Hong, and Gordon 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 September include:

• SFDA Circulates Guidelines for Monitoring Adverse Events Involving Medical Devices
• SFDA Issues Letter Soliciting Public Comments on Communication Methods for Responsible Food and Drug Safety
• Swiss Drugmaker Novartis Expands in China
• China to Divide Emergency Patients into Four Classes for Medical Treatment
• China’s Biopharmaceutical Industry to Accelerate Internationalization
• MOH surveys Clinical Application of Antimicrobials
• Medtronic Opens Orthopedic R&D Center with Weigao
• DHL Establishes Second Life Science and Health Care Logistics Center in Beijing

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

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This post was written by Susan Edwards, Elizabeth Carder-Thompson, Gail Daubert, Celeste Letourneau, and Debra McCurdy.

On Friday, October 7, 2011, the Centers for Medicare & Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") (collectively, the "Agencies") announced they were soliciting nominations from sponsors of medical devices to participate in the Agencies’ parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the "Notice"), with an effective date of November 10, 2011, although the Agencies began accepting nomination submissions October 7.

To read the full alert, which summarizes the Notice and discusses potential implications for manufacturers that may be considering participation in the pilot program, click here.

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This post was written by Gary A. Jeffrey.

The Reference Manual on Scientific Evidence, Third Edition has recently been released by the National Academies Press. This work is a substantial update to the prior version, which was first published in 2000, and is intended as a guide to the federal judiciary in assessing complex scientific, economic and engineering issues. In addition to revisions to existing chapters there are four new sections on Forensic Identification Expertise, Exposure Science, Neuroscience, and Mental Health. Of special interest is the new Reference Guide on Exposure Science, which is meant to compliment the sections on epidemiology and toxicology by describing the methods used in estimating the dose of a potentially toxic material to which persons may have been exposed. The newly drafted section on Neuroscience covers the use of neuroimaging or scans to assess an individuals claims concerning pain, and in the context of a criminal proceeding diminished capacity, sanity and honesty. The Third Edition may be purchased form National Academies Press or a free PDF version downloaded at their website (registration required).
 

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