The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be "delisted" by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, such as when a PSO chooses to voluntar

Original title: “Patient Safety Organizations: Voluntary Relinquishment for symplr PSO”

Referred to the Committee on Agriculture, Nutrition, and Forestry. (text: CR S1825)

Original title: “SRES 676: A resolution recognizing and honoring National Mushroom Day and the contributions of Chester and Berks Counties to the national mushroom industry and to healthy diets.”

On April 18, President Trump issued an Executive Order directing the U.S. Department of Health and Human Services (HHS) to accelerate access to treatments for patients with serious mental illness, including devastating, complex, and treatment-resistant conditions.

Original title: “FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order”

Referred to the Committee on Natural Resources, and in addition to the Committees on Energy and Commerce, and Agriculture, 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 8473: Veterinary Services to Improve Public Health in Rural Communities Act”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 8442: To amend title XXVII of the Public Health Service Act to establish civil liability for health insurance issuers with high levels of claims denials.”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 8432: To provide the Food and Drug Administration needed authorities to carry out its regulatory mission with respect to human foods, to provide additional resources and authorities with respect to human foods research, and for other purposes.”

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.

Original title: “Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust”

The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological p

Original title: “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability”

The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs) from the holders of those ANDAs. The basis for the withdrawal is that the ANDA holders have repeatedly failed to file required annual reports for those ANDAs.

Original title: “Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications”

Today, Congress is taking the first step on appropriations to fund the Food and Drug Administration’s FY27 operations, including the critical work the FDA does to evaluate therapies for rare […] The post The EveryLife Foundation submitted a statement to Congress urging lawmakers to support the inclusion of funding for the Rare Disease Innovation Hub appeared first on EveryLife Foundation for Rare Diseases.

Original title: “The EveryLife Foundation submitted a statement to Congress urging lawmakers to support the inclusion of funding for the Rare Disease Innovation Hub”

CMS and FDA announce the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.

Original title: “CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices”

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

Original title: “S 4329: A bill to amend title X of the Public Health Service Act to prohibit family planning grants from being awarded to any entity that performs abortions, and for other purposes.”

The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace.

Original title: “Unnamed pharma files citizen petition targeting FDA’s trove of rejection letters”

The Rural Communities Opioid Response Program--Behavioral Health Care Technical Assistance (RCORP-TA) strengthens, through technical assistance, rural organizations' capacity to develop multi- sector consortia that can plan, implement, and sustain programs that improve access to and quality of behavioral health care services, including substance use disorder/opioid use disorder services. This funded extension extends RCORP-TA's one cooperative agreement award recipient from cohort fiscal year 20

Original title: “Notice of Funding Extension for the Rural Communities Opioid Response Program-Behavioral Health Care Technical Assistance”

The Food and Drug Administration (FDA, the Agency, or we) is adding constituents to the list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke (the established HPHC list) as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Original title: “Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Kimberly Schaff Kiehl for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. Kiehl was convicted of two felonies under federal law. The factual basis supporting Ms. Kiehl's conviction, as described below, is conduct relating to the importation into the United States of a dru

Original title: “Kimberly Schaff Kiehl: Final Debarment Order”