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Food and Drug Administration (FDA) › Healthcare › Exemptions

Epstein Becker & Green

FDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners

Epstein Becker & Green on

In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more

Stinson - Benefits Notes Blog

New Law Permits Stand-Alone Health Reimbursement Arrangements (HRAs) For Small Employers

Stinson - Benefits Notes Blog on

On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more

McDermott Will & Emery

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

McDermott Will & Emery on

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

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