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.

FDA’s efforts to combat drug shortages include a flexible regulatory approach towards getting alternatives towards market and muscular public relations activity aimed at making the public aware of its efforts as it pushes for legislation to expand its powers.

The most recent example of that one-two punch at the problem was an unusual Feb

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