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20 earlier
The Food and Drug Administration (FDA) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the third year of the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with the assessment tool and process. The continuation of this volunta
Original title: “Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program”
The Food and Drug Administration (FDA or we) is requesting information on the current uses and safety data of butylated hydroxyanisole (BHA) in human food and as a food contact substance. We are requesting this information as part of our systematic process for conducting post-market assessments of chemicals in food. We are conducting a post-market assessment of the safety of BHA in food, considering the latest state of the science. We intend to use the information received and any other availabl
Original title: “Butylated Hydroxyanisole (BHA); Request for Information”
This proposed rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also includes provisions relat
Original title: “Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program”
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) is seeking nominations for membership on the Advisory Council for the Elimination of Tuberculosis (ACET). ACET consists of 10 experts including the Chair in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care deliver
Original title: “Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis”
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 proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a continuing information collection project titled School-Based Active Surveillance (SBAS) of Myalgic Encephalomyelit
Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”
Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”
Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”
Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”
Original title: “National Institute of General Medical Sciences; Cancellation of Meeting”
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to renew the collection of expenditure estimate forms for the tribal child support program through an optional financial reporting form, Tribal Budget and Narrative Justification Template (Office of Management and Budget #: 0970-0548; expiration date May 31, 2026). Minor changes are proposed. OCSE does not plan to renew either the Word v
Original title: “Proposed Information Collection Activity; Tribal Budget and Narrative Justification Template”
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 Generic Clearance for the Collection of Qualitative Feedback on Agency Service Deliv
Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”
The Consolidated Appropriations Act of 2026 acts as a first step in addressing prescription drug pricing challenges related to the role of pharmacy benefit managers (PBMs). In a bipartisan effort, the Consolidated Appropriations Act of 2026 was passed by the Senate in a 71-29 vote on January 30 and signed into law on February 3.1 The law included major provisions to address the role of pharmacy benefit managers (PBMs) in the steadily increasing prices of prescription drugs for patients on Medicare Part D. This also affects patients, she says, as patients in the deductible phase will still need to pay full list price for prescription drugs, whereas employers are getting money back through their PBM. “The consumer is always penalized for high list prices, which doesn’t seem right. Doesn’t seem like the reason that you’re trying to have health care in the first place for your employees,” she said. With the passing of the Consolidated Appropriations Act comes an attempt to increase transparency in the way that PBMs operate. Payers need to be publishing their negotiated drug prices so that patients can understand what their drugs cost and make sure that PBMs are passing along all rebates to the employer, which could result in lower out-of-pocket costs and lower premiums. “We are making real progress as an industry. I’m actually quite hopeful because at least there’s some data out there. Things that are percentage-based arrangements, whether they be retaining a portion of the rebates, whether they be collecting a data fee or administrative fee that is tied to the price of the drug, those can no longer be sources of revenue for either the PBMs or their affiliates,” Dresser said. The law also allows CMS to act as an arbiter for disputes between plan sponsors, network pharmacies, and PBMs.
Original title: “New Legislation Aims to Address Transparency in PBMs as First Major Step in Reform | AJMC”
The U.S. Food and Drug Administration today launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food.
Original title: “FDA Launches Assessment of BHA, a Common Food Chemical Preservative”
The agency flagged several violations at a compounding pharmacy owned by Hims & Hers, including “infestation by rodents, birds insects, and other vermin.”
Original title: “Hims & Hers’ Woes Compound as FDA Hits Company With Warning Letter”
Read twice and referred to the Committee on Commerce, Science, and Transportation.
Original title: “S 3257: A bill to require the Administrator of the Federal Aviation Administration to revise regulations for certain individuals carrying out aviation activities who disclose a mental health diagnosis or condition, and for other purposes.”
Read twice and referred to the Committee on Finance.
Original title: “S 2426: A bill to amend title XVIII of the Social Security Act to provide pharmacy payment of certain services.”
Referred to the House Committee on Energy and Commerce.
Original title: “HR 7145: To amend title XIX of the Social Security Act to establish a definition of essential health system in statute and for other related purposes.”
Leptospirosis clinical, patient care, and laboratory guidance for healthcare providers.
Original title: “Clinical Overview of Leptospirosis”
MuGSI helps identify trends, antimicrobial resistance, and risk factors for these infections.
Original title: “Multi-site Gram-negative Surveillance Initiative (MuGSI)”