To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
The bill creates denial of petitions whose primary purpose is to delay approval of certain applications Subparagraph (E) of section 505(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. It relies on definition changes, grants, compliance mandates, and product standards. The main policy areas are Healthcare Consumers and Healthcare.
Who Benefits and How
Patients and health care consumers affected by the bill could gain revenue opportunities and Public beneficiaries or protected communities affected by the clause could face reduced risk.
Who Bears the Burden and How
Federal, state, or local agencies responsible for implementing the clause would take on compliance duties.
Key Provisions
- Creates denial of petitions whose primary purpose is to delay approval of certain applications Subparagraph (E) of section 505(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
The bill creates denial of petitions whose primary purpose is to delay approval of certain applications Subparagraph (E) of section 505(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Key Policy Areas
Healthcare Consumers, Healthcare
Primary Purpose
The bill creates denial of petitions whose primary purpose is to delay approval of certain applications Subparagraph (E) of section 505(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Policy Domains
Whole bill
Identified Gains
- Patients and health care consumers affected by the bill
- Public beneficiaries or protected communities affected by the clause
Identified Costs
- Federal, state, or local agencies responsible for implementing the clause
Sponsors
Legislative Progress
IntroducedMr. Sorensen introduced the following bill; which was referred to …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
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