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FDA Releases New Enforcement Policy for OTC Sunscreen Drug Products Marketed Without an Approved Application
  • Holland & Knight LLP
  • USA
  • June 20 2018

In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed


FDA Guidance on HCEI and Communications to Payors of Unapproved Products and Uses
  • Holland & Knight LLP
  • USA
  • June 15 2018

On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With


FDA Announces Modernization of Drug Review Process and Operations
  • Holland & Knight LLP
  • USA
  • June 7 2018

On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug


HHS Releases RFI to Request Input on Drug Pricing Proposals Read more:
  • Holland & Knight LLP
  • USA
  • May 29 2018

On May 14, 2018, HHS issued a request for information (RFI) on the administration's "American Patients First" drug pricing policy blueprint. The RFI


Congress Continues Push on Medical Device Cybersecurity Mandates
  • Holland & Knight LLP
  • USA
  • May 21 2018

Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing


FDA’s New Pharma Shame Game
  • Holland & Knight LLP
  • USA
  • May 18 2018

On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used


White House Unveils Proposal on Drug Pricing
  • Holland & Knight LLP
  • USA
  • February 13 2018

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the


Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology
  • Holland & Knight LLP
  • USA
  • December 11 2017

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software


Digital Health: FDA Announces New Policy for Genetic Testing Regulation
  • Holland & Knight LLP
  • USA
  • November 7 2017

In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017


Second CAR-T Cell Therapy Approved by FDA
  • Holland & Knight LLP
  • USA
  • October 23 2017

Less than two months after approving the first gene therapy for use in the U.S., that of Novartis's Kymriah for treatment of pediatric patients with