Endocrinologic

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 6 yes, 9 no in regards to whether the efficacy and safety data provide substantial evidence to support approval of the new drug application for dapagliflozin in treating type 2 diabetes.

Bad News For Diabetes Drug From Bristol-Myers, AstraZeneca 2011

The agency then sought the advice of medical experts on its Endocrinologic and Metabolic Advisory Committee about whether the analysis was sufficient, given that clinical studies were completed before the agency changed its guidelines.

Panel OKs Diabetes Drug 2009

On July 30, 2007, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA met to discuss the risks associated with Avandia and concluded that the use of the drug was associated with a greater risk of myocardial infarction, angina, or sudden death than placebo, or other diabetes drugs such as metformin or sulfonylureas.

Studies Find More Health Risks With Avandia 2007

The FDA's joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 to recommend that the regulatory body OK orlistat 60 mg capsules for over-the-counter OTC use in the U.S.

FDA Panel OKs OTC 'Fat Pill' From Garnier's Glaxo 2006

FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting , held on May 19, 2011.

Forbes.com: News Larry Husten 2011

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee had voted 13 - 7 in favor of approving the candidate and concluded that the potential benefits associated with the use of Contrave outweighed the potential risks.

unknown title 2011

The final verdict is highly awaited since the candidate did not receive the backing of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in July 2011.

unknown title 2011

In July, the Agency will present assessments of all available evidence on the cardiovascular safety of Avandia to a joint meeting of the Endocrinologic and metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

WRAL.com Top Stories 2010

In July, the Agency will present assessments of all available evidence on the cardiovascular safety of Avandia to a joint meeting of the Endocrinologic and metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

WRAL.com Top Stories 2010

"We look forward to discussing the efficacy and safety data of Qnexa with the members of the Endocrinologic and Metabolic Drugs Advisory Committee."

Medlogs - Recent stories 2010