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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications”

The Office of Early Childhood Development (ECD) is requesting a 3-year extension with revisions to annual reporting instruments under Office of Management and Budget (OMB) Control #: 0970-0614. This includes proposed revisions to the Demographic and Service Utilization Data Report (DSUR), an extension of the Performance Measurement Data Report (PMR) with no changes, and announces the discontinuation of the Quarterly Performance Report (QPR).

Original title: “Submission for Office of Management and Budget Review; Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Demographic and Service Utilization Data Report and Performance Measurement Data Report”

The Office of Child Support Enforcement (OCSE) is proposing to collect data for a new implementation and outcomes study, Evaluation of the Next Generation Child Support Employment Services Demonstration (NextGen).

Original title: “Proposed Information Collection Activity; Evaluation of the Next Generation Child Support Employment Services Demonstration-New Information Collection Request”

FDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.

Original title: “FDA Expands AI Capabilities and Completes Data Platform Consolidation”

Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.

Original title: “Unforced errors flummox HHS’ radical transparency bid—again”

FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.

Original title: “FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 8526: To amend the Public Health Service Act to update quality standards for mammography facilities for the use of AI systems, and for other purposes.”

Facing increasing pressure from both industry and the White House, FDA Commissioner Marty Makary said the strong bad press against him is “corporate spin” and that the agency has “followed the science.”

Original title: “Makary defends Replimune melanoma rejection again as FDA tensions build”

India's National Policy for Rare Diseases positions the country among global leaders. Learn about expanded Centres of Excellence, financial aid, and indigenous research. Rs 50 lakh assistance sounds good on paper, but when you see the actual cost of life-saving therapies, it's still a drop in the ocean. The customs duty exemption is helpful though. We need more indigenous research - that's the real game changer. Dr. Bahl's point about developing our own model is bang on! 👏 ... As someone who works in healthcare research, I appreciate the government's efforts. But we need to talk about the high cost of orphan drugs. The policy is implemented via Centres of Excellence, which have expanded from 8 to 15, including two in northeast India. Financial assistance has been increased to Rs 50 lakh, and life-saving drugs have been exempted from basic customs duty. The Indian Council of Medical Research is actively working on indigenous research and context-specific models for diagnosis and treatment. The Union Health Secretary also informed that the financial assistance under the policy has been progressively enhanced to Rs 50 lakh, enabling improved access to treatment for patients suffering from identified rare diseases. Acknowledging the rising cost of therapies, she informed that the government has taken proactive steps to exempt life-saving drugs from basic customs duty, with further expansion announced in the recent Union Budget. Highlighting ongoing efforts by ICMR, Dr. Bahl stated that the Council is actively working to expand the range of tools available for managing rare diseases.

Original title: “India's Rare Disease Policy: Comprehensive National Framework”

Information on how to download and use CDC mobile apps including Solve the Outbreak and Health IQ.

Original title: “CDC Mobile Activities”

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 OTARMENI (lunsotogene parvec-cwha), appro

Original title: “Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha)”

The Food and Drug Administration (FDA) is classifying the device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples. We are taking this action because we have determined that c

Original title: “Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples”

The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order (E.O.) 14168, "Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government," issued on January 20, 2025. Specifically, this proposed rule, if finalized, will remove the term "gender" wherever it appears and either replace it with the term "sex," or delete r

Original title: “Modification of Certain Terminology in Title 21”

The Food and Drug Administration (FDA) is classifying the circulating tumor cell enrichment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the circulating tumor cell enrichment device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We

Original title: “Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device”

The Food and Drug Administration (FDA or Agency) has determined that DEXAMETHASONE (dexamethasone) elixir, 0.5 milligrams (mg)/5 milliliters (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 regulator

Original title: “Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

The Food and Drug Administration (FDA) is classifying the corneal storage medium with preservatives including antifungals into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the corneal storage medium with preservatives including antifungals. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance

Original title: “Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals”

The Administration for Children and Families (ACF) intend to request from the Office of Management and Budget (OMB) an extension of approval for an umbrella generic clearance for information collections related to ACF program office monitoring activities. ACF programs promote the economic and social well-being of families, children, individuals, and communities. The Generic for ACF Program Monitoring Activities allows ACF program offices to collect standardized information from recipients that r

Original title: “Proposed Information Collection Activity; Generic for Administration for Children and Families Program Monitoring Activities”

This proposed information collection will use multiple methods to gather information from Tribal Leaders and Tribal Temporary Assistance for Needy Families (TANF) leaders, staff, and participants. The purpose of these activities is to gather systematic information directly from Tribal TANF program leaders, staff, and participants about (1) their challenges, successes, and support needs related to Tribal TANF data reporting requirements; and (2) their research and evidence needs related to Tribal

Original title: “Submission for Office of Management and Budget Review; Next Steps for Tribal TANF Research and Data (New Collection)”

The Office of Child Support Enforcement, Administration for Children and Families (ACF), is requesting a 3-year extension of the Federal Case Registry (FCR)(Office of Management and Budget (OMB)# 0970-0421, expiration November 30, 2026). There are no changes requested to the FCR.

Original title: “Proposed Information Collection Activity; Federal Case Registry”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 8484: Hazard Pay for Health Care Heroes Act”