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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

 
 Topics  Advisory Committee
 Date  Details Biomedtracker Likelihood Of Approval 1

Research needs for the evaluation of potential adverse health effects in children associated with oral cadmium exposure; cross-cutting regulatory science research activities and the FDA's recent Focus Areas of Regulatory Science report

Science Board

Dec. 8 (teleconference)

Meeting notice

 

Cytokinetics' omecamtiv mecarbil to reduce the risk of cardiovascular death and heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction

Cardiovascular and Renal Drugs

Dec. 13 (teleconference)

Meeting notice

84%

Regeneron Pharmaceuticals' supplemental biologics license application for aflibercept solution for intravitreal injection, submitted in response to FDA’s pediatric written request for studies in the treatment of retinopathy of prematurity


Dermatologic and Ophthalmic Drugs


Jan. 9 (teleconference)


Meeting notice

 79%

Cidara Therapeutics' rezafungin lyophilized powder for injection for treatment of candidemia and invasive candidiasis in adults

Antimicrobial Drugs

Jan. 24 (teleconference)

Meeting notice

 99%

1 Biomedtracker LOA as of Dec. 2, 2022



 




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