Original title: “National Library of Medicine; Notice of Partially Closed Meeting”

The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.

Original title: “Biotech leaders call for streamlining of INDs as FDA’s Trialblazer rolls out”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS)

Original title: “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TD

Original title: “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability”

Original title: “National Institute of Environmental Health Sciences; Notice of Partially Closed Meeting”

Original title: “National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Partially Closed Meeting”

Original title: “National Institute of Nursing Research; Notice of Partially Closed Meeting”

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts." This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies the Agency's recomme

Original title: “Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Angela Anatilde Baquero from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Angela Anatilde Baquero was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of

Original title: “Angela Anatilde Baquero: Final Debarment Order”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Ricardo Andres Acuna from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ricardo Andres Acuna was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any d

Original title: “Ricardo Andres Acuna: Final Debarment Order”

The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.

Original title: “Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies”

This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2027. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2027. It also finalizes the third and final of the 3-year phaseout of the rural adjustment, which began in F

Original title: “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program”

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of May 6, 2026, to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order (E.O.) 14168, "Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government," issued on January 20, 2025. Specifically, this proposed rule, if finalized, will remove the term "gender

Original title: “Modification of Certain Terminology in Title 21; Reopening of the Comment Period”

This final rule removes duplicative and unnecessary sections from the Family Violence Prevention and Services Program regulations. These amendments will streamline the Family Violence Prevention and Services regulations and make them more accessible to the public.

Original title: “Reducing Bureaucracy and Burden in Family Violence and Prevention Services”

This final rule updates the hospice wage index, payment rates, and aggregate cap amount for fiscal year 2027. This final rule also includes an analysis of Medicare non-hospice spending, including details regarding a hospice service and spending variation index, and finalizes the requirement that hospices provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Additionally, this rule finalizes conforming changes to discharge from hospice care

Original title: “Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements”

Hollis believes governments should ... disease treatments to make them more accessible. “Maybe we could put aside money, which would be applicable as a subsidy to purchase drugs that are for ultra-rare diseases, with some threshold that [is] appropriate,” he suggested. Like Vitarello, Lauffer wants to see a better clinical trial system for these sorts of therapies, like that ... Hollis believes governments should help support insurers and subsidize ultra-rare disease treatments to make them more accessible. “Maybe we could put aside money, which would be applicable as a subsidy to purchase drugs that are for ultra-rare diseases, with some threshold that [is] appropriate,” he suggested. Like Vitarello, Lauffer wants to see a better clinical trial system for these sorts of therapies, like that proposed by the MHRA. Newer therapy options potentially curative gene therapies, are on the horizon if challenges around funding and reimbursement can be addressed. Similarly, in February, the FDA proposed a change in the regulatory system for ultra-rare disease therapy development, called the Plausible Mechanism Framework. This proposal suggests that sponsors can seek approval when randomized controlled trials are not feasible if they show a well‑supported, biologically plausible mechanism such as an ASO treatment correcting a mutation, good data, and convincing evidence that the therapy hits its target and improves outcomes. If something goes wrong … it also helps me justify my decisions towards the patient, towards the clinicians, towards the hospitals and institutions as well.” · Two key issues in getting ASOs or other therapies to people with ultra-rare genetic diseases are how to pay for and regulate them to make sure that they are as safe as possible, but also get to patients in time.

Original title: “From Mila to Many: Making Ultra-Rare Disease Therapies More Accessible | Inside Precision Medicine”

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

Original title: “S 5137: CARE for Mental Health Professionals Act”