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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.

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Featured Council Members

GLG Council Members are leading experts including academics, scientists, and industry specialists

Jim Farley, President, Cardinal Consulting and Training

Jim FarleyWhat is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

PresidentCardinal Consulting and Training

Gregory Glover, Partner, Pharmaceutical Law Group PC

Gregory GloverWhat is a GLG Educator?|GLG Educators have qualified for GLG Member Programs and are therefore eligible to participate in ongoing in-depth consulting projects with GLG clients.What is a Premium Council Partner?|Premium Council Partners are leading Professional Service Firms that work exclusively with GLG.

PartnerPharmaceutical Law Group PC

Bret Koplow, Partner, Head of Food & Drug Practice, SONNENSCHEIN, NATH & ROSENTHAL, LLP

Bret KoplowWhat is a GLG Educator?|GLG Educators have qualified for GLG Member Programs and are therefore eligible to participate in ongoing in-depth consulting projects with GLG clients.What is a Premium Council Partner?|Premium Council Partners are leading Professional Service Firms that work exclusively with GLG.

Partner, Head of Food & Drug PracticeSONNENSCHEIN, NATH & ROSENTHAL, LLP

Marc Scheineson, Partner & Chair, Food and Drug Practice, ALSTON & BIRD LLP

Marc ScheinesonWhat is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Partner & Chair, Food and Drug PracticeALSTON & BIRD LLP

Barry Massie, MD, Chief of the Cardiology Division , San Francisco Veterans Affairs Medical Center

Barry Massie, MDWhat is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Chief of the Cardiology Division San Francisco Veterans Affairs Medical Center

Browse all 226 Leading Experts

Recent Live Meetings

Interactive roundtables, private visits, and small scale seminars are types of GLG Live Meetings

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

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. 

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.

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...

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.

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...

Browse all 1708 GLG News Analyses

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