Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Flu Vaccine Strains Get Easy OK From FDA Panel, But Desire For More Efficacy Remains
US advisory committee overwhelmingly supports WHO's influenza vaccine strain selections, although data are limited as to why current vaccines are not more effective.
Pregnancy Labeling: US FDA Ponders Whether Changes Needed To Overcome Risk Misperceptions
Risk Communication Advisory Committee will opine on impact that Pregnancy and Lactation Labeling Rule has had in conveying safety evidence useful to making prescribing decisions for pregnant patients and whether current labeling language can be improved upon.
Pacira's Exparel: US FDA Panel Narrowly Rejects Nerve Block Claim
Inconsistent efficacy data and safety concerns about falls and systemic toxicity lead to advisory committee vote against a labeling expansion for the local anesthetic; Pacira's proposed revisions to the drug's existing infiltration claim also meet some resistance.