Healthcare Law Today

FEBRUARY 1, 2022

Improves clinical trials by requiring the Food and Drug Administration (FDA) to issue guidance on the use of digital health technologies in clinical trials; decentralized clinical trials; and other innovative designs to support development of new drugs. Senators Murray and Burr expect the legislation to progress this year.

COVID-19 98

COVID-19 FDA Public Health Health Services Administration 98

Innovaare Compliance

JANUARY 15, 2024

6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. Contact Inovaare for expert guidance on navigating these transformations. Rebates from the selected drugs may change.

Medicare 52

Medicare Medicare Compliance FDA 52

Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

FDA 40

FDA Public Health Compliance Hospitals 40

SQA

MAY 24, 2023

As in the past, the PCPC stands ready to collaborate with the FDA and other stakeholders to ensure any reorganization enables the beauty and personal care industry to continue to provide innovative, safe, and effective products while maintaining consumer trust. The PCPC looks forward to working with FDA Chief Scientist Namandjé Bumpus, Ph.D.,

FDA 40

FDA Licensing Governance Compliance 40