Drug Shortages: Can The Blame Game Help Find Solutions?
The effort to prepare for and prevent drug shortages resembles a “he said, she said” argument between FDA, practitioners and industry, where the actual cause of many shortages remains a matter of debate.
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Gray Market Investigation Could Push Track-and-Trace Debate
Rep. Cummings and Sen. Rockefeller suggest serialization is not an adequate replacement for state pedigree laws in letter to House and Senate leaders conferencing on user fee bills.
User Fee Bills: After Mark-ups, How Will House And Senate Reconcile Differences?
House and Senate committee user fee bill mark-ups approaching, but drafts have differences in drug shortage, supply chain security and other proposed policy changes to reconcile.
Drug Shortage Senate Draft: FDA Told To Look For Impact Before Leaping Into Enforcement
Proposal would require shortage consideration before FDA issues an enforcement action, which could ensure enforcement and shortage staff continue talking.