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Results: 1-10 of 276

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


Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps
  • Mintz Levin
  • USA
  • October 3 2017

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration


Building a Health App? What You Need to Know
  • Mintz Levin
  • USA
  • September 18 2017

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an


FDA Takes First Steps to Cut Regulations, Solicits Public Feedback
  • Mintz Levin
  • 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
  • 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