The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile. The pharma refused.

Original title: “FDA Ties Amgen’s Rare Inflammatory Disease Drug to Eight Deaths, Dozens of Liver Injuries”

A series of controversial policy changes directed by the HHS secretary have left experts fearful of the future implications for public health.

Original title: “A ‘hijacked plane’: CDC, under RFK Jr.’s influence, trades science for dogma”

Constant leadership changes and erratic decision-making have left the biopharmaceutical industry feeling its chief regulator is as unpredictable as it’s ever been.

Original title: “FDA, after turbulent year, leaves drugmakers guessing on its direction”

Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?

Original title: “Trump’s MFN Pricing Expected To Delay More European Drug Launches”

Information on the Cholera and Other <em>Vibrio </em>Illness Surveillance (COVIS) system.

Original title: “Cholera and Other <em>Vibrio </em>Illness Surveillance”

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 YUVIWEL (navepegritide), approved Februar

Original title: “Issuance of Priority Review Voucher; Rare Pediatric Disease Product; YUVIWEL (navepegritide)”

The Food and Drug Administration (FDA or Agency) has determined that INAPSINE (droperidol) injection, 2.5 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

Original title: “Determination That INAPSINE (Droperidol) Injection, 2.5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by the International Association of Color Manufacturers (IACM or petitioner), proposing that we amend the color additive regulations to no longer provide for the use of three specified solvents (methylene chloride, trichloroethylene, and ethylene dichloride) for preparing certain color additives because these uses have been permanently abandoned.

Original title: “Filing of Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Proposed Collection: 30-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute)”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Research Data Center Data Security Forms for Access to Confidential Data. NCHS plans

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

The Food and Drug Administration (FDA or we) is requesting data and information to help make an evidence-based determination that balances food safety, regulatory clarity, and industry interest regarding a potential update to the acceptable market name for the following fish: Sebastes alutus, Sebastes borealis, Sebastes ciliatus, Sebastes crameri, Sebastes entomelas, Sebastes flavidus, Sebastes goodei, Sebastes levis, Sebastes melanops, Sebastes miniatus, Sebastes ovalis, Sebastes paucispinis, S

Original title: “Consideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information”

Original title: “Statement of Organization, Functions, and Delegations of Authority; Office of The National Coordinator for Health Information Technology”

The Administration for Children and Families (ACF) proposes to extend approval of the existing overarching generic clearance for Reviewer Recruitment Forms (Office of Management and Budget (OMB) #: 0970-0477). No changes are proposed to the terms of the overarching generic. Burden estimates have been updated.

Original title: “Submission for Office of Management and Budget Review; Generic Clearance for Reviewer Recruitment Forms”

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

Washington, D.C. — Congressman Greg Murphy, M.D., introduced the Provider Reimbursement Stability Act, legislation to modernize and update the underlying mechanics of the Medicare Physician Fee Schedule (MPFS) to improve stability for physicians and their patients. It just makes sense that we take care of the people who take care of us, and provide them with fairness and predictability so they can continue to provide quality care for patients across the country." "The bipartisan Provider Reimbursement Stability Act (PRSA) would reverse a damaging trend that negatively impacts healthcare providers nationwide," said Congressman John Joyce, M.D. Because when doctors are supported, patients benefit." "Physicians across Iowa and the country are facing growing uncertainty under a broken and outdated reimbursement system," said Congresswoman Mariannette Miller-Meeks, M.D. "Stability in reimbursement is stability in access, especially in rural America. I’m proud to co-lead the Provider Reimbursement Stability Act to bring predictability, fairness, and long-overdue updates to how providers are paid. "We all want our doctors to deliver personalized, effective care to patients, which is directly affected by Medicare assuring fair and accurate compensation to providers," said Congressman Brad Schneider. "When Medicare’s estimates for different health care services are wrong, it automatically, and inappropriately cuts doctor pay across the board in order to stay 'budget neutral.’ The Provider Reimbursement Stability Act seeks to fix these errors and limit unintended payment reductions by introducing reforms that promote stability and fairness in Medicare physician payments. "When Congress established the current Medicare physician payment system a decade ago, it failed to account for inflation," said Congressman Bob Onder, M.D. "As a result, throughout the COVID-era inflation, medical expenses increased while physician reimbursement declined, forcing many doctors to limit or stop seeing Medicare patients altogether. Our seniors deserve better, and the Provider Reimbursement Stability Act will establish long-overdue guardrails against physician pay cuts unrelated to quality and ensure seniors have equal access to care as non-Medicare patients."

Original title: “Murphy Introduces Legislation to Improve Medicare Reimbursement Stability | Congressman Greg Murphy”

EMA’s human medicines committee (CHMP) has issued a draft qualification opinion for a new methodology in preclinical research, which can reduce the overall number of…

Original title: “EMA consults on virtual control groups to help reduce animal use in medicines development”

Digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research. As outlined in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have committed to supporting the use of DHTs in drug and biologica

Original title: “Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments”

The Food and Drug Administration (FDA) is announcing the availability of its decision on a request for a hearing regarding the proposal of FDA's Center for Drug Evaluation and Research (CDER) to refuse to approve a new drug application (NDA) 218489, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules (85 mg) with the proposed indication for "the treatment of [symptoms of] or [nausea in] in gastroparesis" ("symptoms of gastroparesis"). The decision is available in the docke

Original title: “Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules”

The ACF OCS announces a preliminary determination that funds from the federal fiscal year 2025 (FY25) Low Income Home Energy Assistance Program (LIHEAP) are available for reallocation to states, territories, tribes, and tribal organizations that received FY26 direct LIHEAP awards. The purpose of this proposed action is to redistribute FY25 annual LIHEAP funds and FY24 and FY25 Infrastructure Investment and Jobs Act (IIJA) funds that recipients were unable to obligate or carry over to FY26. No su

Original title: “Proposed Reallotment of Fiscal Year 2025 Funds for the Low Income Home Energy Assistance Program”