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
GLG Council Members are leading experts including academics, scientists, and industry specialists
Of CounselWILEY REIN LLP
PresidentCardinal Consulting and Training
PartnerPharmaceutical Law Group PC
Of CounselWILEY REIN LLP
PresidentCardinal Consulting and Training
Study groups are populations of experts knowledgeable on specific sub-topics within a broader industry
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 EDTMay 5, 2010 | Webcast
Webcast: FDA Recall Issues and Impact on Medical Device Manufacturers (10:30 AM EDT/7:30 AM PDT)October 28, 2010 | Webcast
Webcast: Current Enforcement Environment at FDA (12:00 PM EDT / 9:00 AM PDT)March 23, 2011 | Webcast
Webcast: Medical Device Manufacturing - FDA Quality Systems and Inspections (11:00 AM EDT)March 10, 2011 | Webcast
Webcast: FDA’s Medical Device “Innovation Pathway” (10:00 AM EST)News analyses are expert commentaries on current events, written by Council Members who are available for follow up consultations
IOM Report on the FDA 510k process
August 5, 2011
Mac McKeen, Faculty Director, College of Continuing Education, UNIVERSITY OF MINNESOTA
FDA Approves Oxecta – PDUFA for Remoxy Due 6/23/11
June 20, 2011
FDA Panel Denies Gout Drug Ilaris (Novartis) ? Concern for Regeneron’s Arcalyst
June 22, 2011
Federal Pre-emption of Pharmaceuticals and Medical Devices: A Murky Landscape
August 4, 2011