Auxilium Xiaflex's Advisory Committee To Focus On Physician Expertise, Training
This article was originally published in The Pink Sheet Daily
Executive Summary
Majority of clinical trial investigators were hand or orthopedic surgeons and FDA asks if this level of expertise is needed to safely use the biologic.
You may also be interested in...
FDA Assesses Its Role In Limiting Physician Access To Auxilium's Xiaflex
Deciding whether to mandate a Risk Evaluation and Mitigation Strategy when the safety of a product may be a function of the health care provider's skill is the question FDA is debating as it reviews Auxilium's Xiaflex for advanced Dupuytren's disease
FDA Assesses Its Role In Limiting Physician Access To Auxilium's Xiaflex
Deciding whether to mandate a Risk Evaluation and Mitigation Strategy when the safety of a product may be a function of the health care provider's skill is the question FDA is debating as it reviews Auxilium's Xiaflex for advanced Dupuytren's disease
Advisory Panel Backs Approval Of Auxilium's Xiaflex, Wants Post-Market Data
Members agree 12-0 that drug is approvable, offer opinion on who should dispense and the amount of training needed.