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Lawmakers Wary As Experts Advocate For New Congressional Regulatory Office Post-Chevron

Lawmakers seemed unconvinced of the feasibility of setting up a new regulatory office to help chart paths forward for Congress in the wake of SCOTUS’ overturn of Chevron deference, as exerts pitched the idea at a House Administration hearing Tuesday (July 23).

Cassidy Introduces Bill That Would Further Restrict Agencies Post-Chevron

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Legislation that would strip FDA of its food regulatory authority was introduced Tuesday (July 23) by Senate Majority Whip Dick Durbin (D-IL) and House Appropriations Committee Chair Rosa DeLauro (D-CT) in a bill that would instead establish a separate agency responsible for food safety and nutrition.

HHS amended a 2013 emergency declaration Tuesday (July 23) to allow for expanded authorities in the response to highly pathogenic avian influenza (HPAI), including allowing FDA to extend the expiration dates of certain medical products and to issue emergency use authorization for unapproved drugs, devices or products.

HHS is granting $25 million to Walgreens for a decentralized clinical trial to evaluate COVID-19 vaccine effectiveness, with the goal of enhancing participation across diverse age groups and ethnic backgrounds while gathering real-world data that can be used to conduct future clinical studies.

HHS’ Office for Civil Rights (OCR) hasn’t changed its approach to privacy rulemaking following the Supreme Court’s decision to overturn its longstanding Chevron doctrine, OCR Director Melanie Fontes Rainer told Inside Health Policy Tuesday (July 23), and is continuing its plans to start enforcing the expanded HIPAA Privacy Rule in December and give patients and providers the tools needed for privacy protection.

The National Institutes of Health (NIH) says artificial intelligence models often misinterpret medical images and fail to explain the reasons behind diagnoses, while legal experts say that with the Supreme Court’s recent overcome of the Chevron doctrine, FDA will need congressional action to establish proper regulation of AI and machine learning software in medical devices.

Pharmaceutical company Merck is seeking to enter the market for respiratory syncytial virus (RSV) vaccines, announcing Tuesday (July 23) it has received positive topline results from a clinical trial evaluating its prophylactic monoclonal antibody for infants, known as clesrovimab.

The ACO Primary Care Flex (PC Flex) model should be universally accessible to all ACOs, the National Association of Accountable Care Organizations (NAACOS) plans to say in its formal feedback to CMS in the coming days.