Faster Approval of Safe Generic Drugs: Lower Medication Costs.
This bill aims to allow the approval of generic drugs when their labeling omits certain safety information protected by patent or exclusivity. Under the proposal, a drug will not be considered ineligible for approval solely because it omits such protected information, provided the Secretary requires the labeling to include appropriate statements necessary to assure safe use.
Key points
Allows approval of a generic drug whose labeling omits protected safety information.
Requires the labeling to include safety statements deemed necessary by the Secretary for safe use.
Prevents blocking drug approval solely based on the omission of protected information in the labeling.
Expired
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