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20 earlier
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 U.S. Tuberculosis Follow-Up Worksheet for Newly Arrived Persons and U.S. Status Adju
Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”
This notice announces the first biannual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2026 to discuss the CMS' preliminary coding, Medicare benefit category, and Medicare payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non-biological items and services, as well as how to register for the meeting.
Original title: “Medicare Program; Public Meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Level II Coding”
Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Center for Health Statistics (NCHS) Data Detectives Camp. The goal of thi
Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”
Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”
The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov.
Original title: “FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results ”
Committee on Health, Education, Labor, and Pensions. Hearings held.
Original title: “S 2355: Patients Deserve Price Tags Act”
Placed on the Union Calendar, Calendar No. 357.
Original title: “HR 2528: Association Health Plans Act”
Referred to the House Committee on Energy and Commerce.
Original title: “HR 2874: Defense of Conscience in Health Care Act”
Almost half of the top 100 medicines vulnerable to supply disruptions in the U.S. have at least one key starting material with a single source country, according to a new report from United States Pharmacopeia.
Original title: “USP adds Tamiflu, Trulicity to vulnerable list as upstream analysis reshapes supply concerns”
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Original title: “FDA flexibility isn't absent but evolving regulations come with growing pains”
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
Original title: “FDA’s CRL transparency policy is boosting biopharma accountability”
The proposed regulations extend electronic prior authorization requirements to medications
Original title: “CMS Proposes Reforms to Speed Patient Access to Drugs | HCI Innovation Group”
HRSA will provide additional funds to the University of Utah, Salt Lake City, Utah, the current EDC Program recipient, to extend the recipient's current period of performance by 12 months. This extension is necessary to support continuity of operations that facilitate pediatric readiness national data collection activities in hospital emergency departments (ED) and prehospital emergency medical services (EMS) agencies throughout the country. The current performance period ends June 30, 2026.
Original title: “Emergency Medical Services for Children Data Center (EDC)”
The Food and Drug Administration (FDA or Agency) has determined that BILTRICIDE (praziquantel) oral tablet, 600 milligrams (mg), 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 BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Original title: “S 4227: Preventing Illegal Laboratories and Protecting Public Health Act of 2026”
Referred to the House Committee on Ways and Means.
Original title: “HR 8242: Health Coverage Tax Credit Reauthorization Act of 2026”
Read twice and referred to the Committee on Veterans' Affairs.
Original title: “S 4220: Veterans Health Administration Novel Therapeutics Preparedness Act”
CMS Proposes Major Reforms to Speed Up Patient Access to Drugs, Increase Transparency, and Reduce Administrative Burden Proposed rule would require faster prior authorization decisions, expand electronic prior authorization to drugs, and increase transparency across federal programs
Original title: “CMS Proposes Major Reforms to Speed Up Patient Access to Drugs, Increase Transparency, and Reduce Administrative Burden | CMS”