Original title: “National Institute on Alcohol Abuse and Alcoholism; Notice of Partially Closed Meeting”

In the consultation, the MHRA said ... rare disease therapies and potentially make medications more affordable”. Where there is limited evidence, patients could gain access to innovative treatments earlierMedicines and Healthcare products Regulatory Agency · Central to the proposal is a new Investigational Marketing Authorisation (IMA) pathway, which would combine clinical trial approval with ... In the consultation, the MHRA said its proposed ‘Rare disease therapies regulatory framework’ would incorporate a compressed regulatory pathway “expected to reduce the cost of developing rare disease therapies and potentially make medications more affordable”. Where there is limited evidence, patients could gain access to innovative treatments earlierMedicines and Healthcare products Regulatory Agency · Central to the proposal is a new Investigational Marketing Authorisation (IMA) pathway, which would combine clinical trial approval with what the MHRA calls a “progressive route” to market authorisation approval. However, the MHRA adds: “While the framework is primarily intended for rare diseases, elements of it… may also be relevant to conditions with higher prevalence where randomised controlled trials are not feasible or are impractical.” · Conventional regulatory guidance for therapy approvals is typically designed for common diseases and assumes large patient populations, validated clinical end-points and phase III confirmatory trials. Of an estimated 10,000 rare diseases, the vast majority still have no effective therapy, according to the Medicines and Healthcare products Regulatory Agency (MHRA), which puts the cost of delayed diagnosis at £340m per year and health-related disability costs at a further £4.7bn. However, up to 3.5 million people in the UK living with rare diseases could access treatments more easily via a new framework proposed by the MHRA in May 2026. The Pharmaceutical Journal from the Royal College of Pharmacy

Original title: “A faster route to rare disease treatments: the MHRA’s proposals - The Pharmaceutical Journal”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 10094: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2026”

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research for the benefit of the public health.

Original title: “Government-Owned Inventions; Availability for Licensing”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 10088: To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to conduct a study to assess the potential for expanding the safe and effective use of reprocessed single-use devices, and for other purposes.”

The Food and Drug Administration (FDA or the Agency) is announcing a formal evidentiary public hearing on the proposal to withdraw approval of the abbreviated new drug application (ANDA) 091695, submitted by Kremers Urban Pharmaceuticals, Inc. (Kremers) for methylphenidate hydrochloride extended-release tablets. On October 18, 2016, the Director of FDA's Center for Drug Evaluation and Research (CDER) published a notice of opportunity for hearing on a proposal to withdraw approval of ANDA 091695.

Original title: “Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets”

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 10100: To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to provide for no-cost coverage for annual screening mammography beginning at 30 years of age.”

Ahead of an approval filing, the drugmaker is amping up a fight against sellers who claim to offer versions of its highly anticipated “triple-G” weight loss medicine.

Original title: “Lilly files six lawsuits in bid to shut down ‘black market’ for retatrutide”

The Biotech Consortium to Accelerate ... therapies for serious neurological and rare diseases, including amyotrophic lateral sclerosis, frontotemporal dementia, Angelman syndrome, and Duchenne muscular dystrophy. BCAI's mission is to keep American clinical trials in the U.S., ... The Biotech Consortium to Accelerate Innovation (BCAI) unites more than a dozen innovative biotechnology companies developing transformative therapies for serious neurological and rare diseases, including amyotrophic lateral sclerosis, frontotemporal dementia, Angelman syndrome, and Duchenne muscular dystrophy. BCAI's mission is to keep American clinical trials in the U.S., so American patients have the earliest possible access to U.S.-developed medical innovation. CAMBRIDGE, Mass.--(BUSINESS WIRE)--A new survey reveals that U.S. biotechnology companies focused on developing treatments for rare and serious diseases overwhelmingly prefer to conduct first-in-human (FIH) clinical trials in the United States. However, historical obstacles posed by the U.S. Through strategic cost-saving initiatives, robust business partnerships, educational and networking opportunities, and proactive advocacy, MassBio empowers its members to launch the next generation of medical advancements to deliver the cures and therapies that enhance patient lives. ... 1U.S. Food and Drug Administration. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers: Guidance for Industry. Instead, they are asking the FDA to implement the 10x safety margin as outlined in the Agency’s own 2005 guidance, Estimating the Maximum Safe Starting Dose in Initial Clinical Trials1. Restore predictable review timelines that reduce costly holds and rework. Strengthen sponsor-reviewer communication so trial design is driven by science, not procedural ambiguity. Ensure better alignment of review criteria with disease severity and life expectancy.

Original title: “New Survey Finds U.S. Biotechs Advancing Treatments for Rare and Serious Diseases Want to Run Clinical Trials in U.S. but Regulatory Hurdles are Sending Them Abroad”

HRSA provides funding to support a national center for newborn screening systems known as the National Center for Newborn Screening Systems Excellence (NBS Excel). In fiscal year 2026, supplemental funding is being provided to NBS Excel to establish a national newborn screening stakeholder workgroup. This workgroup will be a pathway for conditions to be considered and recommended for inclusion in the Recommended Uniform Screening Panel (RUSP) and to discuss national- level issues related to newb

Original title: “National Newborn Screening Stakeholder Workgroup”

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce." This guidance supersedes a previous guidance, entitled "Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables," issued in 2008, and is a final guidance to the draft guidance for industry entitled "Guide to Minimize Food Safety Hazards of Fresh-Cut Produce" issued in 2018. The gu

Original title: “Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability”

This document withdraws a proposed rule that was published in the Federal Register on January 11, 2008. The proposed rule would have amended the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations at 45 CFR 1355.40 and the appendices to Part 1355 to modify the requirements for States to collect and report data to ACF on children in out-of-home care and in subsidized adoption or guardianship arrangements with the State. This document also withdraws the provision of the 200

Original title: “Adoption and Foster Care Analysis and Reporting System”

The Office of the Assistant Secretary for Health (OASH) is seeking nominations for membership on the National Vaccine Advisory Committee (referred to as NVAC and/or the Committee). The NVAC is a federal advisory committee within the U. S. Department of Health and Human Services (HHS). Management support for the activities of this Committee is the responsibility of the Office of the Assistant Secretary for Health (OASH). The qualified individuals will be nominated by the Assistant Secretary for H

Original title: “Solicitation of Nominations for Membership on the National Vaccine Advisory Committee”

The executive order — which wasn’t accompanied by any new scientific evidence — aims to split the MMR vaccine into three separate shots and revives the administration’s attempt to slim down the immunization schedule.

Original title: “Trump signs order seeking to upend childhood vaccine schedule”

This notice with comment period provides information to the public on the process CMS will use to provide accelerated Medicare coverage through the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for new innovative technologies. The RAPID coverage pathway leverages existing processes to provide expedited national Medicare coverage for eligible technologies. This notice with comment period solicits public comment on the proposed RAPID coverage pathway.

Original title: “Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway”