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 75

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: 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


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


FDA Takes First Steps to Cut Regulations, Solicits Public Feedback
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • September 11 2017

Since our March 17th post about President Trump's executive actions aiming to implement his deregulatory agenda, several important developments


FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • September 5 2017

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy


Food Identity Disputes Continue to Impose High-Profile Pressure on FDA
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • August 20 2017

As we reported on previously (see here and here), FDA recently tussled with the manufacturer of an innovative vegan condiment called “Just Mayo” based


Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • August 9 2017

On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc


August 2017 Is Here - Will FDARA Get Done Soon?
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • August 2 2017

The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the