Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 5582: Patients Deserve Price Tags Act”

Read twice and referred to the Committee on Finance.

Original title: “S 3389: Lowering Health Care Costs for Americans Act”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 9949: To require the Secretary of Health and Human Services to conduct a study on the impacts of arsenic, cadmium, mercury, and lead in infant formula on infant health and establish standards for regulating the content of such substances in infant formula.”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 9948: To direct the President to establish an interagency task force to review, and provide recommendations on, the impact of addictive design features on youth mental health, to direct the Secretary of Health and Human Services to establish grant programs to support the activities of the task force, and for other purposes.”

Referred to the Committee on House Administration, and in addition to the Committees on Education and Workforce, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 9967: To amend the Congressional Accountability Act of 1995 to provide enhanced enforcement authority for occupational safety and health protections applicable to the legislative branch, to provide whistleblower protections and other antidiscrimination protections for employees of the legislative branch, and for other purposes.”

High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

Original title: “The FDA was all in on AI. Will that change?”

AstraZeneca is trying to invoke the Orphan Drug Act to protect its blockbuster, on the grounds it is approved to treat a rare pediatric condition. Last year, Otsuka sought to block competitors on the grounds that Abilify had been approved to treat a rare disease, but a different judge ruled against the drug maker. “AstraZeneca now seeks extraordinary relief,” Landmon said, including an order to bar generic competitors until May 27, 2023, “despite the fact that another court has already endorsed FDA’s ability to permit a (generic) applicant to carve out pediatric labeling protected by orphan drug exclusivity under nearly identical facts.” “Additional competition in the prescription drug market—including generic options—is crucial to lowering prescription drug prices and providing patients with more affordable choices.” · Crestor lost patent protection July 8, 2016, but AstraZeneca had pre-emptively sued FDA to block rivals. AztraZeneca sought to invoke the Orphan Drug Act to thwart generics, on the grounds that only Crestor had approval to treat a rare pediatric condition that elevates cholesterol. US District Judge Randolph Moss ruled late Tuesday that the drug maker was not likely to win a lawsuit seeking another 7 years of protection for Crestor, and thus denied AstraZeneca’s request for a temporary restraining order.

Original title: “Judge Denies Order to Keep Generic Crestor Competitors Off the Market | AJMC”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 5059: A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 5056: CDC Tribal Public Health Security and Preparedness Act”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 9820: CDC Tribal Public Health Security and Preparedness Act”

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biolog

Original title: “Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability”

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER)

Original title: “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability”

HHS gives notice of a decision to designate a class of employees from the Savannah River Site in Aiken, South Carolina, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

Original title: “Designation of a Class of Employees for Addition to the Special Exposure Cohort”

The Food and Drug Administration (FDA) is amending a notice entitled "Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026" that appeared in the Federal Register on September 18, 2025. The notice established the FY 2026 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat medical countermeasure, or tropical disease priority review voucher and outlined the payment proc

Original title: “Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction”

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Spe

Original title: “Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability”

ANA is issuing final interpretive rules, general statements of policy, and rules of agency organization, procedure, or practice relating to the following Fiscal Year (FY) 2026 Notices of Funding Opportunity (NOFOs): Economic Advancement Grants for Local Empowerment (EAGLE), AI3 Action Institute--Artificial Intelligence for American Indians (AI3 Action Institute), and the National Center for Native Training and Technical Assistance (NCNTTA).

Original title: “Notice of Final Issuance on the Adoption of Administration for Native Americans Program Policies and Procedures”

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 9699: Drug Deal Disclosure Act”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 5134: Green New Deal for Health Act”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 9972: American Patients First Act of 2026”

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Science, Space, and Technology, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 9962: Green New Deal for Health Act”