The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is inviting public comments on a request to extend approval of forms approved for the Placement and Transfer of Unaccompanied [Alien] Children into ORR Care Provider Facilities. Recently, ORR received emergency approval from the Office of Management and Budget (OMB) for form revisions that ensure that ORR can continue to properly enact its mandates and comply wi

Original title: “Submission for Office of Management and Budget Review; Placement and Transfer of Unaccompanied (Alien) Children Into Office of Refugee Resettlement Care Provider Facilities”

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Original title: “Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine)”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Laboratory Animal Welfare (OLAW), Office of the Director (OD), National Institutes of Health (NIH), 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; Chimpanzee Research Use Form (Office of the Director)”

Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.

Original title: “Ongoing Regulatory Uncertainty Means Innovation Is Now Higher Risk”

An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.

Original title: “Proliferating Patents, Lawsuits Stave Off Pharmas’ Generic Competitors”

CDC offers fellowship, internship, and training opportunities for students and professionals.

Original title: “About Fellowships and Training Opportunities”

CDC has a network of country and regional offices in over 60 countries.

Original title: “Our Global Presence”

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 ZEVASKYN (prademagene zamikeracel), appro

Original title: “Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZEVASKYN (Prademagene Zamikeracel)”

The U.S. Food and Drug Administration (FDA) will host “Rare Disease Day 2026” on February 23, aiming to engage with patients and the broader… Instead, this approach intends to address areas of unmet need where traditional trials would be infeasible, and where data from such bespoke treatment can inform regulatory decisions regarding the product. We see the plausible mechanism pathway as an extension of FDA's increasing willingness to use its regulatory flexibility and recognizing the challenges in the development of drugs and biologics for rare diseases, unmet need, regenerative medicines, and “n-of-1” therapies in particular. Real-world evidence use. When clinical trials struggle to enroll patients, as is often the case for rare diseases, sponsors employ creative tactics to use RWD to support bids for approval, including turning to natural history cohorts. Advance regulatory science of rare disease therapies, including by enhancing opportunities for consideration of novel endpoints, biomarker development and assays, innovative trial design, RWE, and statistical methods. The U.S. Food and Drug Administration (FDA) will host “Rare Disease Day 2026” on February 23, aiming to engage with patients and the broader community to advance development of rare disease treatments. Ahead of the event, we are taking a look at FDA's latest regulatory science and transparency initiatives in the space, including the agency's Rare Disease Hub Strategic Agenda, mechanisms for accelerating rare disease development programs, and guidance on chemistry, manufacturing and controls (CMC) for cell and gene therapies.

Original title: “Rare disease round-up: FDA efforts to advance treatments - Lexology”

This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

Original title: “Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area (High Point Regional Health)”

The Food and Drug Administration (FDA, Agency, or we) has determined that TOLECTIN DS (tolmetin sodium) capsule, equivalent to (EQ) 400 milligrams (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tolmetin sodium, capsule, EQ 400 mg base, if all other legal and regulatory requirements are met.

Original title: “Determination That TOLECTIN DS (Tolmetin Sodium) Capsule, Equivalent to 400 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

Original title: “Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area (Alleghany County Memorial Hospital, Inc.)”

This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

Original title: “Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area (WRMC Hospital Operating Corporation)”

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

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

Johns Hopkins’ Thomas Hartung discusses how drug discovery and development will change under evolving regulatory policies that embrace AI technology as well as organoid and other non-animal models of human biology.

Original title: “As FDA Moves Away From Animal Testing, AI and Organoids Can Shine”

The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.

Original title: “Biopharma Must Cope With The Fetal Bovine Serum Squeeze”

The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.

Original title: “Moderna’s mRNA Vaccine Refusal Comes Amid Global Advanced Therapies Push”

Access the latest diabetes statistics, including data on prevalence and medical costs.

Original title: “A U.S. Report Card”

Overview of CDC's work in Nigeria.

Original title: “CDC in Nigeria”