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Literature DB >> 26246760

The Food and Drug Administration and the Future of Drug Development for the Treatment of Diabetes.

Eric P Brass.

Abstract

Entities: Disease

Year: 2014 PMID： 26246760 PMCID： PMC4522876 DOI： 10.2337/diaspect.27.2.75

Source DB: PubMed Journal: Diabetes Spectr ISSN： 1040-9165

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8 in total

1. From the Food and Drug Administration.

Authors:
Journal: JAMA Date: 2000-05-03 Impact factor: 56.272

2. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus.

Authors: Benjamin M Scirica; Deepak L Bhatt; Eugene Braunwald; P Gabriel Steg; Jaime Davidson; Boaz Hirshberg; Peter Ohman; Robert Frederich; Stephen D Wiviott; Elaine B Hoffman; Matthew A Cavender; Jacob A Udell; Nihar R Desai; Ofri Mosenzon; Darren K McGuire; Kausik K Ray; Lawrence A Leiter; Itamar Raz
Journal: N Engl J Med Date: 2013-09-02 Impact factor: 91.245

Review 3. Risk assessment in drug development for symptomatic indications: a framework for the prospective exclusion of unacceptable cardiovascular risk.

Authors: Eric P Brass; Roger J Lewis; Raymond Lipicky; James Murphy; William R Hiatt
Journal: Clin Pharmacol Ther Date: 2006-03 Impact factor: 6.875

8. Assessing the benefit-risk for new drugs: are the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the Division of Metabolism and Endocrinology Products in sync?

Authors: Eric P Brass
Journal: Diabetes Care Date: 2013-05-21 Impact factor: 19.112

8 in total

1 in total

Review 1. Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements.

Authors: Fred Yang; Murray Stewart; June Ye; David DeMets
Journal: Diabetes Metab Syndr Obes Date: 2015-07-20 Impact factor: 3.168

1 in total

The Food and Drug Administration and the Future of Drug Development for the Treatment of Diabetes.

1. From the Food and Drug Administration.

2. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus.

Review 3. Risk assessment in drug development for symptomatic indications: a framework for the prospective exclusion of unacceptable cardiovascular risk.

4. Current issues in non-inferiority trials.

5. Improving the FDA's advisory committee process.

6. Identifying and addressing safety signals in clinical trials.

7. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes.

8. Assessing the benefit-risk for new drugs: are the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the Division of Metabolism and Endocrinology Products in sync?

Review 1. Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements.