GLG Topic: 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.
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Leading Experts: Food and Drug Administration (FDA)
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Jim FarleyPresident
Cardinal Consulting and Training
Jim Farley is an Independent Consultant and Owner of Cardinal Consulting and Training. Formerly, Mr. Farley served as the Director of the Science Branch of Philadelphia District FDA. He has over 30 years of experience in pharmaceutical and pharmaceutical packaging industries with extensive experience...
Volunteer Professor of Law
University of Cincinnati - CC
James O'Reilly is Volunteer Professor of Law at University of Cincinnati, where he has counseled large and small drug, biotech, device and food firms since becoming a full time professor in 1998. Prof. O’Reilly’s 31 books and 137 articles have been widely cited, and as an FDA expert over many years...
Marc ScheinesonPartner & Chair, Food and Drug Practice
ALSTON & BIRD LLP
Marc Scheineson is a Partner with Alston & Bird where he heads the firm's Food and Drug Law Practice. He has practiced food and drug law, health care law and administrative law for over 20 years in national law firms and at the FDA. His practice focuses on determining the regulatory course of least...
Tim Gallagher, RPhExecutive Vice President of Pharmacy Operations
ASTRUP DRUG, INC.
Tim Gallagher, RPh, is the Executive Vice President of Pharmacy Operations at Astrup Drug, Inc. Minnesota. He manages all aspects of pharmacy operations for the company. Mr. Gallagher has been a practicing Pharmacist for over 20 years in both the chain and independent community pharmacy setting. He...
Keith Berman, MPH, MBAFounder
Health Research Associates
Keith Berman, MPH, MBA, is the Founder of Health Research Associates. He provides reimbursement consulting, market research and new business planning services to the biomedical products industry. Mr. Berman's technology focus includes biopharmaceuticals, medical devices, and human blood-derived products....
Study Groups: Food and Drug Administration (FDA)(?)
GLG NewsSM
Analysis: Food and Drug Administration (FDA)(?)
The FDA’s approval of Abilify for treatment of acute manic and mixed episodes of pediatric Bipolar Disorder is a very important milestone. Treatment with Abilify already has had growing off-label use in the pediatric population, in both acute and chronic settings, because of its favorable...
In this publications there is am implication that the FDA will approve things faster as the FDA will after hiring so many people with fancy science backgrounds. This might be true but it probably won't be the case.
The F.D.A. is the nation's most ubiquitous regulatory agency; every American encounters F.D.A.-regulated products many times every day. Fulfilling a "gatekeeper" function -- which means that regulators must approve drugs, biologics and medical devices before they can be marketed -- the agency's...
The FDA -- likely with encouragement of King Pharmaceuticals -- has ordered ZymoGenetics to cease dissemination of materials that cite "a significantly lower incidence of antibody formation compared to the commercially available bovine thrombin product [Thrombin-JMI]." "This statement is false or misleading...
The FDA is investigating Merck's Singulair for a possible link to suicidal thought and action. With over 28 million prescriptions last year and a 12 year record of safety in children and adults, the evidence must be evaluated closely before coming to any conclusion. Of note antihistamines, including...
GLG InstituteSM
Seminars: Food and Drug Administration (FDA)(?)
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