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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
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12 April 2024
Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety....
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03 April 2024
On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies...
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02 April 2024
The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...
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01 April 2024
On February 16, 2024, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part...
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20 March 2024
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its guidance concerning compliance obligations for HIPAA covered entities and business...
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19 February 2024
The U.S. Department of Health and Human Services (HHS) has finalized amendments to more closely align the Part 2 substance use disorder (SUD) regulations with HIPAA. These changes have the...
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09 January 2024
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical...
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09 January 2024
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical...
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15 December 2023
The U.S. Biden administration announced Thursday that 28 health care providers and payers have signed the White House’s voluntary commitment aimed at ensuring the safe development of...
