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Life Sciences › Notice of Proposed Rulemaking (NOPR)

Gardner Law

Changes Proposed to HIPAA Security Rules

Gardner Law on

On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected...more

Quarles & Brady LLP

Brace Yourself: DEA’s Final Rule on Quotas Squeezes Inventory Levels and Signals Further Supply Restrictions

Quarles & Brady LLP on

On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more

Epstein Becker & Green

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

Epstein Becker & Green on

The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more

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