Comments on the Food and Drug Administration (FDA) Cardiac and Renal Drugs Advisory Committee Recommended Guidelines for the Conduct of Antianginal Drug Trials

1994 ◽  
pp. 251-253 ◽  
Author(s):  
Udho Thadani
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Drug Trials ◽  
Recommended Guidelines

Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

2021 ◽  
Vol 10 (3) ◽  
pp. 122-122
Author(s):  
Charles L Bennett
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Safety And Efficacy ◽  
Biological Drug ◽  
Drug Products ◽  
Fda Approval ◽  
The Us ◽  
Approval Letter

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.

scholarly journals Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings

JAMA ◽  
2006 ◽  
Vol 295 (16) ◽  
pp. 1921 ◽  
Author(s):  
Peter Lurie ◽  
Cristina M. Almeida ◽  
Nicholas Stine ◽  
Alexander R. Stine ◽  
Sidney M. Wolfe
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Conflict Of Interest ◽  
Food And Drug Administration ◽  
Financial Conflict ◽  
Drug Advisory Committee

Overview of the 2014 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee Meeting About Vorapaxar

Circulation ◽  
2014 ◽  
Vol 130 (15) ◽  
pp. 1287-1294 ◽  
Author(s):  
Nevin C. Baker ◽  
Michael J. Lipinski ◽  
Thibault Lhermusier ◽  
Ron Waksman
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Committee Meeting
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