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Efforts to Cut Drug Prices in Medicaid
  • Manatt Phelps & Phillips LLP
  • USA
  • February 27 2018

Over the past five years, the budgets of state Medicaid programs have been challenged by the introduction of new high-cost drugs into the marketplace


FDA, FTC Try to Stop Opioid Cessation Products
  • Manatt Phelps & Phillips LLP
  • USA
  • February 8 2018

Marketers of opioid cessation products received warning letters from the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC


FDA and Digital Health: Understanding New Guidance Documents
  • Manatt Phelps & Phillips LLP
  • USA
  • January 25 2018

The Federal Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is now accepting comments on its December 8, 2017 Draft


The Eight Key Elements of Effective Compliance Programs
  • Manatt Phelps & Phillips LLP
  • USA
  • January 25 2018

Mandated compliance programs are not a new concept, but they have evolved over time. The Deficit Reduction Act of 2005 required all Medicaid


No Love Lost for FDA Over Granola Ingredients
  • Manatt Phelps & Phillips LLP
  • USA
  • October 26 2017

The Food and Drug Administration showed no love for Nashoba Brook Bakery’s granola by sending a letter to the Massachusetts business instructing it to


Weight Loss Drug Gains FDA Warning About False Advertising
  • Manatt Phelps & Phillips LLP
  • USA
  • June 15 2017

In the first warning letter sent since President Donald J. Trump took office, the Food and Drug Administration (FDA) cautioned the maker of a weight


The Goldilocks Theory of Bringing Change to the FDA
  • Manatt Phelps & Phillips LLP
  • USA
  • May 24 2017

The nomination of Dr. Scott Gottliebwho has now been confirmed to lead the Food and Drug Administration (FDA)drove another Goldilocks debate. Like


Faxed Dinner Invite May Violate TCPA, Second Circuit Rules
  • Manatt Phelps & Phillips LLP
  • USA
  • March 21 2017

The U.S. Court of Appeals for the Second Circuit handed a loss to a pharmaceutical company in a Telephone Consumer Protection Act action, reversing


Regulatory Concerns Around Big Data, Artificial Intelligence and the IoT
  • Manatt Phelps & Phillips LLP
  • USA
  • January 23 2017

Data is everywhere. By some estimates, 90 of the world's data has been created in the last two years. This deluge is only going to intensify as the


FDA Releases Interim Guidance on “Healthy” Labeling
  • Manatt Phelps & Phillips LLP
  • USA
  • October 14 2016

New interim guidance from the Food and Drug Administration eased the restrictions on foods that can be labeled as "healthy," and provides insight as