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Device Modernization Series: FDA’s Changes to the 510(k) Program
  • Mintz
  • USA
  • February 20 2019

In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of


Another caution for employers in medical marijuana states
  • Constangy Brooks Smith & Prophete LLP
  • USA
  • February 20 2019

A positive test may not equate to impairment. Those of us who have spent a lot of time in the world of drugs (gee, that doesn't sound right) know that


EPA Issues New Waste Rules for Hospitals, Medical Clinics and Pharmacies
  • King & Spalding LLP
  • USA
  • February 19 2019

The U.S. Environmental Protection Agency (“EPA”) recently issued new regulations for managing pharmaceutical waste under the Resource Conservation and


Drug pricing week in review: Ways and Means hearing, new bipartisan legislation
  • DLA Piper
  • USA
  • February 19 2019

This past week, the House Ways and Means Committee held another installment in an ongoing series of important Congressional hearings examining the


CBD “Edibles” Face Opposition from States, FDA
  • Epstein Becker Green
  • USA
  • February 13 2019

Gummies, brownies, sodas, cookies . . . Consumer appetite for food and dietary supplement Products Containing cannabidiol (“CBD”) has grown over the


HHS Proposed Rule on Prescription Drug Safe Harbors
  • Ropes & Gray LLP
  • USA
  • February 11 2019

On January 31, 2019, the Office of Inspector General ("OIG") of the U.S. Department of Health & Human Services ("HHS" or the "Department") released a


ML Strategies Health Care Preview - Week of February 11, 2019
  • Mintz
  • USA
  • February 11 2019

With Valentine’s Day approaching, love may be in the air - but not so much on Capitol Hill. Talks to reach a Border Security deal ahead of Friday’s


HHS Issues Proposed Rule to Remove Safe Harbor for Drug Rebates
  • K&L Gates
  • USA
  • February 11 2019

On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if


A 2018 Review of Drug and Device Products Liability Claims and Issues to Watch
  • Taft Stettinius & Hollister LLP
  • USA
  • February 11 2019

A number of important announcements from the Food and Drug Administration (FDA) in 2018, as well as a variety of court decisions, will undoubtedly


FDA Issues Final Guidance on Least Burdensome Provisions for Medical Devices
  • Barnes & Thornburg LLP
  • USA
  • February 7 2019

Congress has directed the FDA to conduct premarket evaluations of medical devices in the least burdensome manner possible, consistent with