The Food and Drug Administration (FDA) is announcing the renewal of the Drug Safety and Risk Management Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Drug Safety and Risk Management Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 31, 2028, expiration date.

Original title: “Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal”

The U.S. Department of Health and Human Services (HHS) is hereby giving notice that the charter for the President's Council on Sports, Fitness & Nutrition (hereafter referred to as the Council) has been renewed.

Original title: “Renewal of the President's Council on Sports, Fitness & Nutrition's Charter”

Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.

Original title: “HR 6238: NIH IMPROVE Act”

Ordered to be Reported by the Yeas and Nays: 44 - 0.

Original title: “HR 5347: Health Care Efficiency Through Flexibility Act”

Ordered to be Reported in the Nature of a Substitute by Voice Vote.

Original title: “HR 3164: Ensuring Community Access to Pharmacist Services Act”

Referred to the House Committee on Foreign Affairs.

Original title: “HR 9015: To authorize assistance to train and retain obstetrician-gynecologists and sub-specialists in urogynecology and to help improve the quality of care to meet the health care needs of women in least developed countries, and for other purposes.”

India’s rare disease policy created hope, but many patients lose treatment once the Rs 50 lakh cap is exhausted. Fourth, the Centre must create a structured framework for states to participate. Some states, including Kerala, Karnataka and Rajasthan, were cited as having moved to support patients through their own mechanisms. This federal pathway deserves to be developed, not left to activism and litigation alone. India’s rare disease policy is in danger of failing in exactly that way. The National Policy for Rare Diseases, 2021, was meant to bring relief to families facing impossible medical odds and impossible treatment costs. It did create hope. But for many patients, that hope now ends at an administrative ceiling of Rs 50 lakh. Recent discussions with patient groups, doctors and former public officials, the reality came through with distressing clarity. Families described a familiar sequence. Diagnosis is delayed. Awareness among frontline doctors is patchy. Treatment pathways are hard to navigate. One example that struck me deeply was the broader desperation surrounding these diseases. Even parliamentarians have found themselves scrambling to mobilise funds for individual patients with conditions such as SMA, where therapies can cost several crores.

Original title: “India’s rare disease policy cannot stop at a funding cap | Policy Circle”

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

Original title: “S 4618: A bill to effectively staff the high-need public elementary schools and secondary schools of the United States with school-based mental health services providers.”

Referred to the House Committee on Education and Workforce.

Original title: “HR 8979: To effectively staff the high-need public elementary schools and secondary schools of the United States with school-based mental health services providers.”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2444-2445)

Original title: “S 4640: A bill to amend the Public Health Service Act to award grants to eligible crisis centers to provide follow-up services to individuals receiving suicide prevention and crisis intervention services, to and the Communications Act of 1934 to improve the accessibility of 9-8-8, and for other purposes.”

Referred to the House Committee on Energy and Commerce.

Original title: “HRES 1282: Recognizing the 75th anniversary of the American College of Obstetricians and Gynecologists and its critical role in advancing the practice of obstetrics and gynecology and the health and well-being of patients through excellence in clinical practice, education, advocacy, and research.”

More than 3.5 million people in ... authorised therapy. Under the current system, developers of rare disease treatments are often required to meet the same standards as medicines designed for common illnesses. That usually means running large clinical trials involving many ... More than 3.5 million people in the UK are currently living with a rare disease, yet fewer than five per cent of these conditions have an authorised therapy. Under the current system, developers of rare disease treatments are often required to meet the same standards as medicines designed for common illnesses. That usually means running large clinical trials involving many patients, and something that is often impossible for diseases affecting only a handful of people worldwide. The Rare Disease Therapies Regulatory Framework would apply to conditions affecting fewer than 1 in 50,000 people, for which standard clinical trials are difficult or unrealistic to conduct. Instead of relying solely on traditional trial models, the proposals would introduce a more flexible, risk-based process that allows treatments to progress through development more quickly while maintaining patient safety. A main part of the Rare Disease Therapies Regulatory Framework is the “Investigational Marketing Authorisation”. This would combine clinical trial approval with a staged pathway towards full market authorisation, potentially allowing patients to access promising therapies earlier than under current rules. Treatments would still need approval from the National Institute for Health and Care Excellence (NICE) before being used on the NHS. The UK’s medicines regulator has set out plans to accelerate the development and approval of treatments for rare diseases

Original title: “MHRA plans could speed up rare disease treatment in the UK with new Rare Disease Therapies Regulatory Framework”

Read twice and referred to the Committee on Finance.

Original title: “S 4583: A bill to amend title XVIII of the Social Security Act to establish a Medicare payment option for patients and eligible professionals to freely contract, without penalty, for Medicare fee-for-service items and services, while allowing Medicare beneficiaries to use their Medicare benefits.”

Referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “SRES 743: A resolution supporting the designation of May 3 through May 9, 2026, as "Children's Mental Health Awareness Week".”

Referred to the House Committee on Agriculture.

Original title: “HRES 1301: Supporting the designation of May 29, 2026, as "Mental Health Awareness in Agriculture Day" to raise awareness around mental health in the agricultural industry and workforce and to continue to reduce stigma associated with mental illness.”

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that expl

Original title: “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability”

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled "Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein." The guidance provides information for manufacturers and contract laboratories that perform PER studies to assist in designing, conducting, evaluating, and reporting PER studies. The guidance explains "appropriate modifications" of AO

Original title: “Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability”

HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).

Original title: “National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy”