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Results: 1-10 of 76

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology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On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology.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


Shortage of Relief: Recent Disasters Highlight Multifaceted Drug Shortage Problem
  • Holland & Knight LLP
  • USA
  • October 19 2017

Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. The


Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform
  • Holland & Knight LLP
  • USA
  • September 18 2017

On September 13, the U.S. House of Representatives Energy and Commerce Committee's Subcommittee on Health held a hearing to examine draft legislation


FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices
  • Holland & Knight LLP
  • USA
  • September 8 2017

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market


Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves First Gene Therapy
  • Holland & Knight LLP
  • USA
  • August 31 2017

FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to


New FDA Digital Health Program
  • Holland & Knight LLP
  • USA
  • August 1 2017

The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in


FDA Announces Several Key Initiatives for Drug and Device Review and Approval
  • Holland & Knight LLP
  • USA
  • July 24 2017

Recently, FDA Commissioner Dr. Scott Gottlieb announced the launch of several FDA initiatives including activities to implement the 21st Century Cures


FDA Announces New Initiatives to Regulate Digital Health Technologies
  • Holland & Knight LLP
  • USA
  • June 15 2017

FDA Commissioner Scott Gottlieb, MD, posted a blog today announcing new FDA initiatives re: regulation of digital health technologies to be piloted