HHS updates civil monetary penalty amounts to reflect inflation adjustments as mandated by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. This regulatory change may impact compliance costs for healthcare organizations.

NORD's virtual event will update attendees on key legislative issues affecting rare disease advocacy in 2026. The session aims to engage participants in ongoing advocacy efforts and highlight opportunities for involvement.

Rare Disease Day, observed on February 28, aims to raise awareness and advocate for equity in healthcare for individuals with rare diseases. Coordinated by EURORDIS and over 70 patient organizations, the campaign highlights the importance of community voices in driving change.

Global Genes announces the launch of RARE-X, a patient-driven initiative aimed at collecting symptom and patient-reported outcome data for rare diseases. This effort seeks to enhance research and understanding of rare conditions through direct patient engagement.

A new NIH-funded study establishes a clear link between severe chronic traumatic encephalopathy (CTE) and increased dementia risk. This research could influence future therapeutic strategies and patient management for individuals with a history of head trauma.

The CDC has launched a new resource page dedicated to providing information for patients and caregivers about preventing falls among older adults. This initiative aims to enhance awareness and support for a vulnerable population.

The CDC has released new guidelines addressing obesity and overweight, emphasizing the need for comprehensive strategies to combat these conditions. The guidelines aim to inform policy decisions and public health initiatives.

The U.S. Department of Health and Human Services rescinded guidance aimed at ensuring nondiscriminatory access to health care at pharmacies. This decision may impact how pharmacies comply with federal civil rights laws regarding access to reproductive health care services.

The FDA has determined the regulatory review period for REZDIFFRA, which is necessary for the patent extension application process. This determination is part of the legal requirements for patent claims related to human drug products.

The CDC is seeking public comment on a proposed data collection project aimed at evaluating support for young breast cancer survivors and those with metastatic breast cancer. This initiative aligns with the agency's goal to reduce public burden and enhance the utility of government information.

FDA has determined the regulatory review period for TRYVIO, which is necessary for a patent extension application. This notice is part of the legal requirements for patent claims related to human drug products.

FDA has determined the regulatory review period for IMAAVY, which is necessary for a patent extension application. This notice is part of the legal requirements for patent claims related to human biological products.

The FDA has determined the regulatory review period for the Symplicity Spyral Renal Denervation System, which is relevant for patent extension applications. This notice is part of the agency's compliance with legal requirements regarding patent claims for medical devices.

FDA has determined the regulatory review period for RYZNEUTA, which is necessary for a patent extension application to the U.S. Patent and Trademark Office. This determination is a procedural step in the patent extension process for this human biological product.

The CDC is seeking public comments on a proposed information collection project aimed at promoting resources for autistic teens and young adults. This initiative aligns with the Paperwork Reduction Act of 1995 and aims to enhance the utility of government information.

FDA has determined the regulatory review period for BIMZELX, which is necessary for a patent extension application. This notice is part of the legal requirements for patent claims related to human biological products.