On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco products on the market as of the August 8, 2016 deeming rule that extended FDA’s regulatory jurisdiction to include all tobacco products. Accordingly, manufacturers of e-cigarettes now have until May 2020 to submit ...
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Recent Updates
- Last Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future
- Indiana Senate Enrolled Act 9 Requires Written Notice of Health Care Entities’ Mergers or Acquisitions
- Connecticut Bill Calls for Office of Health Strategy to Develop a Plan Regarding Private Equity Firms in Health Care
- Revised OCR Guidance Provides New Examples, but Raises More Questions, Regarding Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates
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