Lilly asked the FDA to step in after claiming that testing it’s done suggests copycat versions of Zepbound may carry “unknown risks.”

Original title: “Lilly warns GLP-1 knockoffs may be ‘dangerous,’ escalating war with compounders”

Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single dashboard will enhance their utility and cut costs, the agency said.

Original title: “FDA to unify agency’s ‘fragmented’ safety surveillance system”

After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice. But recent decisions call into question whether shared evidence and prior knowledge will accelerate development in rare diseases.

Original title: “Why Industry Is Questioning FDA’s Data-Sharing Push in Cell and Gene Therapy”

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

Original title: “S 4061: A bill to amend the Elementary and Secondary Education Act of 1965 to require local educational agencies to include mental health and suicide prevention information on student identification cards, and for other purposes.”

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

Original title: “S 4048: A bill to amend the Public Health Service to require the Secretary to award grants, contracts, or cooperative agreements to eligible entities to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes, and for other purposes.”

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

Original title: “S 4066: A bill to provide that the approved application under the Federal Food, Drug, and Cosmetic Act for the drug mifepristone for the purpose of the termination of intrauterine pregnancy is deemed to have been withdrawn, to establish a Federal tort for harm to women caused by chemical abortion drugs, and for other purposes.”

In this episode of Denatured, you'll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA's latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.

Original title: “From Two Trials to One, Sponsors Face a Higher Standard”

Read twice and referred to the Committee on Finance.

Original title: “S 3908: SOS: Sustaining Outpatient Services Act”

CDC’s National Healthcare Safety Network is the nation’s most widely used healthcare-associated infection tracking system.

Original title: “5-Step Enrollment for Long-term Care Facilities”

Guía para padres y cuidadores para asegurarse de que su hijo/a esté al día con las vacunas recomendadas durante la infancia.

Original title: “Vacunas recomendadas para niños”

This document corrects typographical and technical errors in the final rule that appeared in the November 5, 2025 Federal Register titled "Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program" (hereinafter referred to as the CY 2026 PFS final rule), specifying finalized changes to the Medicare physici

Original title: “Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction”

This notice announces the Catastrophic Health Emergency Fund (CHEF) threshold established at $19,630 for Fiscal Year 2026 CHEF requests.

Original title: “Catastrophic Health Emergency Fund (CHEF) Fiscal Year 2026 Threshold”

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying system of records 09-90-0024 "HHS Financial Management System Records" to update the legal authorities, clarify the purpose descriptions, add a new routine use, and revise an existing routine use. The system of records is maintained by HHS' Office of the Assistant Secretary for Financial Resources (ASFR) and covers records retrieved by personal identifier abo

Original title: “Privacy Act of 1974; System of Records”

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Original title: “Watson Laboratories, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications”

In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health Office of the Director (OD) 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; NIH Information Collection Web Interface and Forms To Support Genomic Data Sharing and NIH Controlled-Access Data Repository Requirements (OD)”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) Office of the Director (OD) Office of Extramural Research (OER) 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; 60-Day Comment Request; NIH Extramural Harassment Web Form (Office of the Director, Office of Extramural Research)”

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

Original title: “S 3598: Better Care for PFAS Patients Act of 2026”

Which rare disease treatments make it to patients? "The hidden kingmaker is not the drug company, it’s insurance," writes CNBC anchor Becky Quick, in setting up her conversation with RA Capital Managing Partner Peter Kolchinsky and Aradigm Health CEO Will Shrank at the network's Cures Summit ... Which rare disease treatments make it to patients? "The hidden kingmaker is not the drug company, it’s insurance," writes CNBC anchor Becky Quick, in setting up her conversation with RA Capital Managing Partner Peter Kolchinsky and Aradigm Health CEO Will Shrank at the network's Cures Summit last week. Which rare disease treatments make it to patients? "The hidden kingmaker is not the drug company, it’s insurance," writes CNBC anchor Becky Quick , in setting up her conversation with RA Capital Managing Partner Peter Kolchinsky and Aradigm Health CEO Will Shrank at the network's Cures Su

Original title: “The role of insurance in rare disease drug funding — RApport”

FDA launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.

Original title: “FDA Launches New Adverse Event Look-Up Tool”

Among the unreported adverse events potentially linked to Ozempic are two deaths and one case of “completed suicide,” according to an FDA inspection report.

Original title: “Novo Hit With FDA Warning Letter for Unreported Ozempic Safety Signals”