Drug Shortage Provisions In Draft PDUFA Bill Would Expedite Major Manufacturing Changes
FDA would have 60 days to review major changes and could “deem” them compliant with current good manufacturing practices so long as the facility has a plan and resources to achieve full compliance and institutes quality control measures under draft legislation being developed by the House Energy and Commerce Committee.
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The public’s acceptance of generic drugs is at an all-time high. But manufacturing issues, shortages of life-saving medications and questions about the overall quality of generics are testing the system like never before. FDA’s tough love message to industry: fix the manufacturing problems—or risk your reputation.
Proposal would require shortage consideration before FDA issues an enforcement action, which could ensure enforcement and shortage staff continue talking.
The Senate measure adds a provision on breakthrough therapies and specifies that accelerated approval provisions do not alter substantial evidence standard used to approve drugs.