Original title: “Home Health Care”

Original title: “Adult Day Services Centers”

Healthcare facilities should consider these actions to reduce water-based health risks.

Original title: “Considerations for Reducing Risk: Water in Healthcare Facilities”

Identify countries and territories at risk for Zika.

Original title: “Countries & Territories at Risk for Zika”

Original title: “Residential Care Communities”

Original title: “Cancer”

Original title: “Hospice Care”

Original title: “Nursing Home Care”

Original title: “Alzheimer Disease”

Learn about CDC's work in the Caribbean, including Jamaica and Trinidad & Tobago.

Original title: “CDC in the Caribbean”

Biography for the acting Director of NCEZID's Division of High-Consequence Pathogens and Pathology.

Original title: “DHCPP Acting Director”

In part two of this four-part series regarding rare diseases, the author examines how economic and structural forces are driving an access gap. As a result, rare disease therapies now account for more than 40% of new drug approvals in recent years.1 · Yet the success of rare disease innovation has exposed a new and increasingly consequential challenge: access. While regulatory systems have adapted to scientific realities, reimbursement and health technology assessment (HTA) frameworks have not kept pace. Patients, clinicians, and manufacturers are encountering a growing disconnect between approval and real-world availability, a phenomenon that has become known as the value–access paradox. Designed for common conditions with large datasets and established comparators, these models systematically disadvantage rare disease therapies. High per-patient costs distributed across small populations yield unfavorable ratios, even when therapies deliver substantial clinical benefit or address severe, life-threatening conditions. Third, payment models must better reflect clinical reality. Outcomes-based agreements, annuity-style payments, and managed entry schemes offer mechanisms to align cost with demonstrated benefit, particularly for one-time or high-cost therapies. While operational complexity has limited adoption, these models are increasingly necessary as traditional insurance structures strain under cumulative orphan drug spending. Ultimately, closing the rare disease access gap requires reframing success. Contrary to common assumptions, rare disease drug development is not uniformly more expensive than development in larger indications. Analyses adjusting for trial size, duration, and capitalized costs suggest that average research and development expenditures for orphan drugs may be lower than for non-orphan therapies.2.3 Smaller trials, greater acceptance of surrogate endpoints, and more flexible regulatory pathways reduce development burden.

Original title: “Rare Disease Treatments: Navigating the Economics of Global Innovation | Pharmaceutical Technology”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BEQVEZ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Matthew Teltser from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Matthew Teltser was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug produc

Original title: “Matthew Teltser: Final Debarment Order”

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice, except in products under the jurisdiction of the United States Department of Agriculture (USDA), infant formula, or foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of

Original title: “Listing of Color Additives Exempt From Certification; Beetroot Red”

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally (except for infant formula, certain foods subject to regulation by the U.S. Department of Agriculture, and foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards

Original title: “Listing of Color Additives Exempt From Certification; Spirulina Extract”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Paul Zachary Lamberty for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Lamberty was convicted of two felonies under Federal law; one felony count for conspiracy and one felony count for introduction of misbranded drugs with intent to defraud and mislead. The factual ba

Original title: “Paul Zachary Lamberty: Final Debarment Order”

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "E22 General Considerations for Patient Preference Studies." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). When finalized, this guidance will provide general principles for the use, design, conduct, analysis, and submission of patient preference studies

Original title: “E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for COBENFY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALFAPUMP and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ALFAPUMP”