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Literature DB >> 15811869

The US Food and Drug Administration Cardiorenal Advisory Panel and the drug approval process.

Dan M Roden¹, Robert Temple.

Abstract

Mesh：

Substances：
Cardiovascular Agents

Year: 2005 PMID： 15811869 DOI： 10.1161/01.CIR.0000161370.77463.0F

Source DB: PubMed Journal: Circulation ISSN： 0009-7322 Impact factor: 29.690

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9 in total

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4. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

Authors: Daniel M Cook; Rama K Gurugubelli; Lisa A Bero
Journal: Drug Saf Date: 2009 Impact factor: 5.606

Review 5. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.

Authors: Rashmi R Shah; Samantha A Roberts; Devron R Shah
Journal: Br J Clin Pharmacol Date: 2013-09 Impact factor: 4.335

The US Food and Drug Administration Cardiorenal Advisory Panel and the drug approval process.

1. The FDA regulatory process for drug and genetic diagnostic test approvals.

2. High-precision recording of the action potential in isolated cardiomyocytes using the near-infrared fluorescent dye di-4-ANBDQBS.

Review 3. Widening the path and window of opportunity for FDA approval of non-vitamin K oral anticoagulant specific antidotes and reversal agents.

4. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

Review 5. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.

6. QTc interval prolongation in children with Ulrich-Turner syndrome.

7. QTc interval prolongation in children with Turner syndrome: the results of exercise testing and 24-h ECG.

Review 8. Class effects and labeling of antihypertensive drugs.

9. Evaluation of the Tp-Te interval, Tp-Te/QTc ratio, and QT dispersion in patients with Turner syndrome.