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Significant Drug Pricing Developments in July - Here’s What You Need To Know
  • Mintz Levin
  • USA
  • July 24 2018

In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments


Biosimilars Action Plan Update
  • Mintz Levin
  • USA
  • July 24 2018

As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018


FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition
  • Mintz Levin
  • USA
  • July 19 2018

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug


FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring
  • Mintz Levin
  • USA
  • July 11 2018

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a


Biosimilars in the Limelight - A Lot Has Happened Since January 2018
  • Mintz Levin
  • USA
  • June 20 2018

A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant


California AG Leads Attack on Lead in Infant Formula
  • Mintz Levin
  • USA
  • June 10 2018

Fresh off a victory in the CA primary, California Attorney General Xavier Bacerra filed suit on June 7, 2018 against Nutraceutical Corporation of Park


FDA Alters Course on Definition of Compounding “Facility” in Final Guidance
  • Mintz Levin
  • USA
  • May 14 2018

Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a


ML Strategies Health Care Preview - Week of April 23rd
  • Mintz Levin
  • USA
  • April 23 2018

The President was slated to speak on drug prices this week in what was a highly anticipated event. Yesterday, word got out that it would be postponed


Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry
  • Mintz Levin
  • 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
  • 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