We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 282

Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • April 18 2018

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include


Report Details Uneven Implementation of the New Drug Tracing Law
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • April 13 2018

Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug


Are HCTPs a Dark Spot in the Sunshine Act Requirements?
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • March 7 2018

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments


NDAANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • January 18 2018

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have


NDAANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • January 18 2018

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have


FDA Resets Enforcement Priorities for OTC Homeopathic Drugs
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • January 2 2018

Happy New Year! And now on to your regular Consumer Product Matters programming Another Federal agency with a consumer-protection mandate has taken a


FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • December 26 2017

This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, which can be found


FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • December 18 2017

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and


FTC Hosts Workshop - “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • November 13 2017

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of


OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • October 10 2017

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee