The Office of the Assistant Secretary for Health (OASH or we) is opening a public docket to solicit input and comments on a proposed threshold for 7-hydroxymitragynine (7-OH) scheduling under the Controlled Substances Act. Public comments submitted to this docket will be provided by the Secretary for Health and Human Services for consideration by the Attorney General.

Original title: “Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information”

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be "delisted" by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, such as when a PSO chooses to voluntar

Original title: “Patient Safety Organizations: Voluntary Relinquishment for the Cassatt Patient Safety Organization”

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 34 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: “Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications”

Ultra-orphan drugs are drugs designed ... small, clinical trial data are limited, which makes it almost impossible to meet traditional insurer thresholds for medical necessity. Enzyme replacement therapies, specialized medical equipment, home care services, and immunotherapy drugs are also frequently denied by insurers for those with rare diseases. The first thing you should do after receiving a denial letter for your rare disease treatment is to determine ... Ultra-orphan drugs are drugs designed for very small patient populations; because the patient pool is so small, clinical trial data are limited, which makes it almost impossible to meet traditional insurer thresholds for medical necessity. Enzyme replacement therapies, specialized medical equipment, home care services, and immunotherapy drugs are also frequently denied by insurers for those with rare diseases. The first thing you should do after receiving a denial letter for your rare disease treatment is to determine the exact reason the insurer is denying the treatment. Rare disease patients face significant medical challenges - denials only complicate them. Many insurance denials can be overturned through... While pharmaceutical companies are prohibited from marketing drugs for unapproved uses, it is both legal and routine for doctors to do so, based on emerging research and clinical judgment. Where rare diseases are concerned, off-label drug use may actually be the accepted standard of care, while still being denied by insurers. Many insurers require step therapy before approving a treatment for a rare disease. Rare disease treatments frequently face insurance hurdles due to high costs, experimental or investigational classifications, and limited long-term clinical data. A few of the specific rare disease treatments that consistently face denial or overly restrictive prior authorization include: Gene and cell therapies, including one-time, potentially curative treatments like Luxturna for inherited retinal dystrophy or Zolgensma for Spinal Muscular Atrophy.

Original title: “Rare Disease Treatment Denied by Insurance - Law Offices of Scott Glovsky”

EMA is launching initiatives to better embed women’s health considerations in medicines development and regulation. Women live longer than men on average but spend more of their…, Advancing developments in women’s health is one of my personal priorities. This is an area where we are seeing strong momentum at EU and global level, and where EMA is…, EMA’s initiatives in this area will be discussed through a dedicated women’s health workshop on 28-29 September. The workshop, broadcast liv

Original title: “EMA steps up efforts on medicines for women’s health”

Supports the development and deployment of standards-based public health information systems.

Original title: “PHIN Vocabulary”

The EveryLife Foundation Emphasizes the Contributions of PFDD Initiatives and Reflects on Legislative Proposals to Modernize Biomedical Research and Regulatory Infrastructure in Two Recent Comments.

Original title: “The EveryLife Foundation Submits Comments to Support Patient-Focused Drug Development and Medical Innovation”

EveryLife Foundation submitted comments in response to Representative Jake Auchincloss’ request for feedback on a legislative discussion draft of the Next-Generation U.S.

Original title: “The EveryLife Foundation Submits Comments in Response to Rep. Auchincloss’ Request”

The EveryLife Foundation for Rare Diseases submitted comments in response to the FDA’s request for information on the impacts of Patient-Focused Drug Development (PFDD) meetings

Original title: “The EveryLife Foundation Submits Comments on the Impacts of PFDD Meetings”

The EveryLife Foundation Emphasizes the Contributions of PFDD Initiatives and Reflects on Legislative Proposals to Modernize Biomedical Research and Regulatory Infrastructure in Two Recent Comments. The EveryLife Foundation for Rare Diseases submitted comments in response to […] The post The EveryLife Foundation Submits Comments to Support Patient-Focused Drug Development and Medical Innovation appeared first on EveryLife Foundation for Rare Diseases.

Original title: “The EveryLife Foundation Submits Comments to Support Patient-Focused Drug Development and Medical Innovation”

EveryLife Foundation submitted comments in response to Representative Jake Auchincloss’ request for feedback on a legislative discussion draft of the Next-Generation U.S. Clinical Development to Accelerate Cures Proposal.  The post The EveryLife Foundation Submits Comments in Response to Rep. Auchincloss’ Request appeared first on EveryLife Foundation for Rare Diseases.

Original title: “The EveryLife Foundation Submits Comments in Response to Rep. Auchincloss’ Request”

The EveryLife Foundation for Rare Diseases submitted comments in response to the FDA’s request for information on the impacts of Patient-Focused Drug Development (PFDD) meetings The post The EveryLife Foundation Submits Comments on the Impacts of PFDD Meetings appeared first on EveryLife Foundation for Rare Diseases.

Original title: “The EveryLife Foundation Submits Comments on the Impacts of PFDD Meetings”

FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.

Original title: “FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing”

Referred to the Committee on Education and Workforce, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 9513: Community Schools and Health Equity Act”

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products — including youth-appealing e-cigarettes — and con

Original title: “FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health”

Referred to the House Committee on Education and Workforce.

Original title: “HR 9486: Health DATA Act of 2026”