FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations
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.
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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.
Interim final rule redefines the terms “sole manufacturer” and “discontinuance.”
Executive order gives FDA no new authority, but will allow doubling of shortage staff and likely bolster issue awareness.