Expert Insights on Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is a U.S. government agency tasked with ensuring that no adulterated or misbranded foods, drugs, or medical devices enter interstate commerce. It also oversees dietary supplements, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. It is also the agency that governs clinical trials of medications.
Gerson Lehrman Group Council Members are available to discuss Food and Drug Administration (FDA) via phone consultations, live meetings, surveys, and other custom GLG products and services.
Find, engage, and manageSM experts today through the GLG platform
Featured Council Members
GLG Council Members are leading experts including academics, scientists, and industry specialists
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Jim Farley
PresidentCardinal Consulting and Training
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Gregory Glover
PartnerPharmaceutical Law Group PC
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Bret Koplow
Partner, Head of Food & Drug PracticeSONNENSCHEIN, NATH & ROSENTHAL, LLP
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Marc Scheineson
Partner & Chair, Food and Drug PracticeALSTON & BIRD LLP
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Barry Massie, MD
Chief of the Cardiology Division San Francisco Veterans Affairs Medical Center
Study Groups
Study groups are populations of experts knowledgeable on specific sub-topics within a broader industry
Recent Live Meetings
Interactive roundtables, private visits, and small scale seminars are types of GLG Live Meetings
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November 6, 2008 | Webcast
GLG Webcast: FDA Drug Reviews - Policies and Procedures - November 6, 2008 at 2:00 PM EDT -
October 28, 2009 | Teleconference
Teleconference: Who Will Win the Anti-Obesity Pill Race? (9:00 AM EST / 13:00 GMT) -
November 3, 2009 | Teleconference
Teleconference: Will Benlysta be the Miracle Drug for Lupus? (10:00 AM EST / 15:00 GMT)
Recent News Analyses
News analyses are expert commentaries on current events, written by Council Members who are available for follow up consultations
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Cepheid Expects H1N1 FDA Approval
October 7, 2009
Ken Powell, President, Genesis Business Development, LLC
Cepheid Eyes EUA from FDA for H1N1 Test | www.genomeweb.com
Cepheid has applied for an Emergency Use Approval (EUA) from the FDA for its molecular H1N1 (swine flu) test. Molecular based tests have been shown to be more accurate than rapid lateral flow assays available marketed by several manufacturers.
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FDA Publishes H1N1 Diagnostic Test Guidance
November 5, 2009
Ken Powell, President, Genesis Business Development, LLC
FDA Publishes Guidance Document for H1N1 Dx | www.genomeweb.com
The FDA published document designed to help diagnostic test manufactures develop H1N1 tests and data that would accompany a FDA application to market them. This follows on the recent issuance of CDC guidelines for H1N1 tests.
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Quest Diagnostics Receives Second FDA H1N1 EUA
October 20, 2009
Ken Powell, President, Genesis Business Development, LLC
FDA Grants Second Authorization for Focus Diagnostics' H1N1 Flu Test | www.genomeweb.com
Quest Diagnostics subsidiary Focus Diagnostics has received a second FDA Emergency Use Authorization for its H1N1 molecular diagnostic test. Marketed under the name Simplexa Influenza A H1N1, it can now be used on 3M's Integrated Cycler by CLIA high-complexity laboratories for the duration of theemergency...
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Fampridine Clears Major Hurdle at FDA Review Panel
October 14, 2009
FDA Panel Backs Proposed Acorda Multiple Sclerosis Drug (fampridine) To Improve Walking | online.wsj.com
Fampridine has been recommended for approval on 10/14. There are several more steps needed at the regulatory level, but the medicine is back on the approval track after a critical pre-meeting FDA report raised serious criticisms.
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FDA Approval for Vermillion's Ovarian Cancer Test
September 17, 2009
Ken Powell, President, Genesis Business Development, LLC
Vermillion's Ovarian Cancer Test Gets FDA OK | www.genomeweb.com
Vermillion's ovarian cancer test joins a handful of In Vitro Diagnostic Multi-Variant Index Assays (IVDMIAs) approved by the FDA. It is the first and only approved IVDMIA ovarian cancer test. Quest Diagnostics, who worked with Vermillion in developing the test, has a three year exclusive to sellit...