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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


FDA Resets Enforcement Priorities for OTC Homeopathic Drugs
  • Mintz
  • 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
  • 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
  • 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