Workshop to Show Companies How to Navigate FDA Approval Process

pills2In an editorial published Tuesday in the Washington Examiner, Paul Howard, Director of the Center for Medical Progress at the Manhattan Institute, decried what he sees as the sluggish and inefficient pace of the U.S. Food and Drug Administration’s drug approval process. According to Howard, it takes a drug company approximately 10 years to bring a new treatment to market.

Tougher FDA requirements for the drug approval process, implemented in the wake of the Vioxx disaster, have added confusion–and, according to drug companies, delays–into the mix for many pharmaceutical manufacturers. With the new requirements, drug developers may be unsure of what to file and how to file.

The medical device industry doesn’t have it any easier: In February, the FDA proposed tougher requirements for the 510(k) review process, which many say will delay the approval of new devices and cost companies valuable capital.

While public safety is rightly of the utmost importance, the new regulations and restrictions imposed by the FDA can turn the approval process into a perplexing, costly quagmire for life science companies. OneMedPlace will be hosting a workshop titled “Registrations to Approvals, Launch and After: Navigating the Current Regulatory Whitewaters” on Wednesday, June 30 at the 2010 OneMedForum. Topics covered will include:

• Changing Requirements and timing of regulatory filing, reviews and approvals. • Post Launch Requirements.

• Good Clinical Practice & BE/BA Bioanalytical Testing FDA Field Reviews.

• New/Tighter policies and requirements for safety and clinical trials for device products.

• USA/EU/Global compliance environment.

• Selection of an Agent and their Responsibilities.

Roy J. Sturgeon, Director of FDA Regulatory Affairs and Compliance at advisory group Gershon Capital & Cie, will be on hand to help participants gain a deeper understanding of the pathway to approval. The workshop is scheduled for Wednesday, June 30, 2010 from 9:00-9:45 a.m.

For more information on this and other workshops at the 2010 OneMedForum, please visit

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