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FDA Advisory Committees

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Latest From Advisory Committees

Scenes From A Shutdown: US FDA Hides It Well

FDA's two recent advisory committee meetings at its White Oak campus offer no obvious clues that agency is struggling due to dwindling carryover balances and furloughed employees.
FDA Leadership

Recent And Upcoming FDA Advisory Committee Meetings

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

Advisory Committees Drug Review

Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee

Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.
Metabolic Disorders Advisory Committees

Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern

US FDA would not have approved Takeda’s Uloric but for a post-market safety study commitment. Now that the study is complete and suggests a potential increased risk of mortality, however, FDA doesn’t seem inclined to pull the product.
Drug Safety Post Market Regulation & Studies

Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear

US FDA advisory committee splits on whether Amgen's osteoporosis drug romosozumab needs observational study or randomized controlled trial to assess cardiovascular risks. 
Advisory Committees Orthopedics

Sanofi's Oral Type 1 Diabetes Drug Approval May Hinge On Ketoacidosis Management

US FDA also questions composite efficacy endpoint used in one of the phase III trials as sotagliflozin reaches advisory committee in attempt to become first approved oral type 1 diabetes treatment. Sanofi says that type 1 diabetes patients already manage DKA risk because it is inherent to their condition and patients did not seem bothered by the instructions to handle DKA.
Metabolic Disorders Advisory Committees
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