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Results:1-10 of 74

Dietary Fiber Expansion Proposed
  • Holland & Knight LLP
  • USA
  • September 13 2018

The FDA recently issued guidance identifying additional isolated or synthetic non-digestible carbohydrates that it intends to propose, adding to the


Labeling of Food Sold in Glass-Front Vending Machines to Be Revised
  • Holland & Knight LLP
  • USA
  • September 13 2018

The U.S. Food and Drug Administration (FDA) proposes to revise the type size labeling requirements for front of package calorie declarations for


CMS Allows Medicare Part D Indication-Based Formulary Design
  • Holland & Knight LLP
  • USA
  • August 30 2018

The Centers for Medicare and Medicaid Services (CMS) has just announced a significant shift in Medicare Part D formulary design to allow Part D


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On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With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