Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

FDA announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions.

Original title: “FDA Advances Drug Repurposing to Address Unmet Medical Needs”

The widely covered impending ouster of FDA Commissioner Marty Makary not long after the exit of controversial biologics head Vinay Prasad highlights the severe turnover rates at the highest rungs of leadership at the health department.

Original title: “Makary’s reported FDA removal could be 'broad positive' for biopharma”

The FDA's decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.

Original title: “Published FDA rejections point to manufacturing, data gaps as key stumbling blocks”

Referred to the House Committee on Natural Resources.

Original title: “HR 8688: Forest Health and Wildfire Risk Reduction Act”

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

Original title: “S 4420: Physical Therapist Workforce and Patient Access Act of 2026”

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that AVLAYAH (tividenofusp alfa-eknm), approve

Original title: “Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm)”

The Administrator of the World Trade Center (WTC) Health Program has received three petitions (Petitions 032, 033, and 068) to add "peripheral neuropathy" to the List of WTC-Related Health Conditions. Upon reviewing the scientific and medical literature, including information provided by the petitioners, the Administrator has determined that there is insufficient evidence available to support taking further action at this time regarding peripheral neuropathy. The Administrator also finds that in

Original title: “World Trade Center Health Program; Petitions 032, 033, and 068-Peripheral Neuropathy; Finding of Insufficient Evidence”

By this interim final rule ("IFR"), the Department of Health and Human Services ("Department") is revising the Department's regulations implementing section 504 of the Rehabilitation Act ("section 504") to extend the compliance dates for the requirements for web content and mobile application ("app") accessibility that were adopted on May 9, 2024. The compliance date for recipients with fifteen (15) or more employees is extended from May 11, 2026, to May 11, 2027. The compliance date for recipie

Original title: “Extension of Compliance Dates for Nondiscrimination on the Basis of Disability; Accessibility of Web Content and Mobile Applications of Recipients of Departmental Financial Assistance”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention." The purpose of this guidance is to assist sponsors in the clinical development of drugs to support an indication of treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI). This guidance finalizes the draft guidance titled "Clostrid

Original title: “Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Postapproval Pregnancy Safety Studies." The purpose of this guidance will be to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA (i.e., pregnancy safety studies) in the postapproval setting. This guidance finalizes the draft guidance of the s

Original title: “Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Pulmonary Tuberculosis: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This guidance finalizes the draft guidance of the same title issued on December 15, 2022.

Original title: “Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability”

The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2028. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders--including patient and consumer advocacy groups, veterinary professionals, and

Original title: “Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate”

The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires September 30, 2028. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders--including patient and consumer advocacy groups, veterinary professi

Original title: “Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate”

If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.

Original title: “Trump signs off on plan to oust embattled FDA Commissioner Marty Makary: report”

The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting to study the safety of drugs and biological products when used during pregnancy.

Original title: “FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics”

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and 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 8716: To amend titles XIX and XXI of the Social Security Act, title XXVII of the Public Health Service Act, the Employee Retirement Security Act of 1974, and the Internal Revenue Code of 1986 to require coverage of self-measured blood pressure monitoring for pregnant and postpartum individuals.”

Referred to the Committee on the Judiciary, and in addition to the Committees on the Budget, and Homeland Security, 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 8690: To address the health needs of incarcerated women related to pregnancy and childbirth, and for other purposes.”

Referred to the House Committee on Veterans' Affairs.

Original title: “HR 8679: To amend title 38, United States Code, to require the Secretary of Veterans Affairs to transmit a veteran's history of opioid prescriptions to a Community Care health care provider.”