Amends the Federal Food, Drug, and Cosmetic Act to expedite approval of priority nonprescription drugs.
The bill amends the Federal Food, Drug, and Cosmetic Act to expedite approval of priority nonprescription drugs. It allows the Secretary of Health and Human Services to designate certain nonprescription drugs as priority nonprescription drugs, facilitating their development and review. Drugs eligible for this designation must be intended for a novel nonprescription indication, be a new molecular entity, or contain an active ingredient not previously available in a nonprescription drug.
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- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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