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Results:1-10 of 83

FDA 2018 Year in Review (and a Few Thoughts on 2019)
  • Mintz
  • USA
  • December 27 2018

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big


Some BPCIA Clouds Begin to Clear: FDA Issues Final Plans for March 2020 “Deemed to Be a License” Provision
  • Mintz
  • USA
  • December 13 2018

In his typical forceful style on December 11, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced several big pieces


FDA's Drug Centers Release New Draft Guidance on Quantitative Info in Consumer-Directed Ads
  • Mintz
  • USA
  • October 17 2018

In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and


Biosimilars Action Plan Update
  • Mintz
  • 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
  • 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
  • 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
  • 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


FDA Alters Course on Definition of Compounding “Facility” in Final Guidance
  • Mintz
  • 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


NDAANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book
  • Mintz
  • 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
  • USA
  • January 18 2018

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