The DEA and HHS have extended telemedicine flexibilities for prescribing controlled medications until December 31, 2026. This decision supports continued access to care for patients requiring controlled substances, reflecting ongoing adaptations in healthcare delivery.

The Office of Refugee Resettlement plans to award a $1 million cooperative agreement to the Welcoming Initiative for Newcomers in San Diego. This funding aims to assess state readiness for implementing a new refugee resettlement framework.

NIOSH has announced its decision to evaluate a petition for including employees from United Nuclear Corporation in Hematite, Missouri, in the Special Exposure Cohort. This could impact compensation eligibility under the Energy Employees Occupational Illness Compensation Program Act.

The FDA released a report under the Modernization of Cosmetics Regulation Act of 2022, finding insufficient data to assess the safety of PFAS in cosmetics. This report highlights ongoing regulatory challenges regarding chemical safety in personal care products.

FDA announces the user fee rates for Over-the-Counter Monograph Order Requests (OMOR) for fiscal year 2026, as part of the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II). This regulatory change impacts qualifying manufacturers and aims to streamline the approval process for OTC drugs.

The HHS has proposed deregulatory actions aimed at enhancing health information technology standards and reducing burdens on developers and providers. This initiative seeks to foster innovation by revising certification criteria and addressing information blocking.

The FDA has received a petition for a partial exemption from premarket notification requirements for radiology computer-aided detection and diagnosis devices. This could streamline the approval process for these technologies, enhancing access to innovative diagnostic tools.

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

FDA grants Emergency Use Authorizations for two new animal drugs to treat New World screwworm infestations in dogs and puppies. Elanco US Inc. is the requesting company for these treatments targeting myiasis caused by Cochliomyia hominivorax.

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

The FDA has determined the regulatory review period for ZELSUVMI, 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 ADZYNMA, which is relevant for patent extension applications. 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 ROMVIMZA, which is necessary for a patent extension application submitted to the USPTO. This determination is a procedural step in the patent extension process for the drug.

FDA has determined the regulatory review period for ALHEMO, a human biological product, as part of the process for patent extension. This determination is a procedural step required by law and relates to the ongoing patent application with the USPTO.

The FDA proposes to withdraw approval of three abbreviated new drug applications due to the ANDA holders' failure to submit required annual reports. This action opens a hearing opportunity for the affected companies to contest the proposal.

The ASTP/ONC has withdrawn its proposed rule on health data interoperability, which aimed to enhance patient engagement and information sharing. This decision follows the closure of the comment period on October 4, 2024, and reflects ongoing challenges in implementing health information technology regulations.