To implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research, and for other purposes.
Summary
What This Bill Does
The bill provides updating FDA regulations to remove pregnant women as a vulnerable research population The purposes of this section are— to facilitate compliance with applicable Federal regulations relating to the protection, provides clearinghouse of clinical trials and registries The Secretary, acting through the Director of the National Institutes of Health, and in consultation with the Commissioner of Food and Drugs and the heads, and provides coordinating Committee on Research Specific to Pregnant and Lactating Women. It relies on appropriations, compliance mandates, reporting requirements, and trade restrictions. The main policy areas are Healthcare Consumers, Healthcare, Education, and Energy.
Who Benefits and How
Patients and health care consumers affected by the bill could gain revenue opportunities, Educational institutions and students affected by the bill could gain revenue opportunities, and Homeowners, tenants, or housing market participants affected by the bill could gain revenue opportunities.
Who Bears the Burden and How
Federal, state, or local agencies responsible for implementing the clause would take on compliance duties, Veterans and VA beneficiaries affected by the bill could lose revenue opportunities, and Patients and health care consumers affected by the bill could lose revenue opportunities.
Key Provisions
- Provides updating FDA regulations to remove pregnant women as a vulnerable research population The purposes of this section are— to facilitate compliance with applicable Federal regulations relating to the protection...
- Provides clearinghouse of clinical trials and registries The Secretary, acting through the Director of the National Institutes of Health, and in consultation with the Commissioner of Food and Drugs and the heads...
- Provides coordinating Committee on Research Specific to Pregnant and Lactating Women.
- Provides raising awareness of research that includes pregnant and lactating women in clinical research The Secretary, acting through the Director of the National Institutes of Health, in consultation with the heads...
- Provides research prioritization process for pregnant and lactating women at the Eunice Kennedy Shriver National Institute of Child Health and Human Development The Director of the National Institutes of Health, acting...
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 provides updating FDA regulations to remove pregnant women as a vulnerable research population The purposes of this section are— to facilitate compliance with applicable Federal regulations relating to the protection, provides clearinghouse of clinical trials and registries The Secretary, acting through the Director of the National Institutes of Health, and in consultation with the Commissioner of Food and Drugs and the heads, and provides coordinating Committee on Research Specific to Pregnant and Lactating Women.
Key Policy Areas
Healthcare Consumers, Healthcare, Education, Energy
Primary Purpose
The bill provides updating FDA regulations to remove pregnant women as a vulnerable research population The purposes of this section are— to facilitate compliance with applicable Federal regulations relating to the protection, provides clearinghouse of clinical trials and registries The Secretary, acting through the Director of the National Institutes of Health, and in consultation with the Commissioner of Food and Drugs and the heads, and provides coordinating Committee on Research Specific to Pregnant and Lactating Women.
Policy Domains
Whole bill
Identified Gains
- Patients and health care consumers affected by the bill
- Educational institutions and students affected by the bill
- Homeowners, tenants, or housing market participants affected by the bill
- Environmental and public health interests affected by the bill
- Researchers and scientific institutions affected by the bill
Identified Costs
- Federal, state, or local agencies responsible for implementing the clause
- Veterans and VA beneficiaries affected by the bill
- Patients and health care consumers affected by the bill
- Energy producers and energy supply-chain firms affected by the bill
- Educational institutions and students affected by the bill
Sponsors
Legislative Progress
IntroducedMs. Castor of Florida (for herself, Mr. Fitzpatrick, and Ms. …
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?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
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