FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations
Executive Summary
Rapid approval of a new, preservative-free generic methotrexate and permission to import an unapproved version of doxorubicin touted at press conference as FDA emphasizes the success of administrative efforts.
You may also be interested in...
GOP Drug Shortage Strategy Pushes FDA Reform, Reimbursement Over Notification
House hearing includes arguments that regulatory delays thwart the market’s response to shortage price signals, suggesting reforms could be included in user fee legislation along with the popular early warning requirement.
FDA’s Drug Shortage Reg Adds More Manufacturers, Products To Notification List
Interim final rule redefines the terms “sole manufacturer” and “discontinuance.”
Obama's Drug Shortage Efforts Focus On Personnel, Persuasion
Executive order gives FDA no new authority, but will allow doubling of shortage staff and likely bolster issue awareness.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: