May 5, 2011

CMS, FDA and the “Parallel Review Process”

Duration: 8 min.

Drug companies and medical device manufacturers must do their homework before undergoing a “parallel review process” of the Food and Drug Administration and the Center for Medicare & Medicaid Services. That’s what Partner Michael Gaba, leader of the firm’s national Healthcare and Life Sciences Team, notes in a webinar about the new joint review system created by the two agencies.

Originally recorded as part of the Bureau of National Affair’s “Thought Leadership” video series, Mr. Gaba says one hurdle for companies to overcome is the agencies’ different missions and styles of review. “The FDA, by its nature, reviews products in a very confidential manner, maintaining the proprietary status of the information submitted by companies,” Mr. Gaba says. “CMS, by comparison, when undertaking a coverage process, does so in a very public manner.”

Mr. Gaba also discusses if the parallel review process can shorten the time for a product to go to market, and whether it can spur venture capital investment in innovative technologies.

Note: Reproduced with permission from the Bureau of National Affairs, "BNA Insights Health Care," BNA Video Insights. Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033)

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