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Results:1-10 of 64

Federal court authorizes pharmaceutical firm to engage in off-label promotion using certain specific information and statements
  • Barnes & Thornburg LLP
  • USA
  • August 13 2015

On August 7, a federal district court in New York preliminarily resolved a closely-watched dispute between the FDA and an affiliate of Amarin


FDA issues draft guidance on direct marking of UDI on devices
  • Barnes & Thornburg LLP
  • USA
  • July 8 2015

The Food and Drug Administration (FDA) recently issued a draft guidance titled, "Unique Device Identification: Direct Marking of Devices." FDA's


FDA issues draft guidance on Voluntary Qualified Importer Program under the Food Safety Modernization Act
  • Barnes & Thornburg LLP
  • USA
  • June 8 2015

The FDA recently issued a draft guidance titled, "FDA's Voluntary Qualified Importer Program" (VQIP). FDA was required to establish the VQIP by the


FDA issues draft guidance on mandatory food recalls under the Food Safety Modernization Act
  • Barnes & Thornburg LLP
  • USA
  • May 27 2015

The Food and Drug Administration (FDA) recently issued a draft guidance titled, "Questions and Answers Regarding Mandatory Food Recalls." FDA was


FDA issues draft guidance on use of patient preference information in certain medical device pre-market submissions and labeling
  • Barnes & Thornburg LLP
  • USA
  • May 27 2015

The Food and Drug Administration (FDA) recently issued a draft guidance titled, "Patient Preference Information - Submission, Review in PMAs, HDE


FDA releases draft guidance on using clinical data from studies conducted outside the United States to support approval of medical devices
  • Barnes & Thornburg LLP
  • USA
  • May 11 2015

The Food and Drug Administration (FDA) recently issued a draft guidance titled "Acceptance of Medical Device Clinical Data from Studies Conducted


FDA releases final guidance on Expedited Access Program for medical devices
  • Barnes & Thornburg LLP
  • USA
  • April 17 2015

Less than a year ago, we published an alert on a draft guidance issued by the FDA titled, "Expedited Approval Program for Premarket Approval Medical


FDA proposes to amend regulations on food facility registration
  • Barnes & Thornburg LLP
  • USA
  • April 16 2015

The Food and Drug Administration (FDA) recently published a Notice of Proposed Rulemaking in the Federal Register concerning the regulations on food


FDA issues final guidance on reprocessing medical devices
  • Barnes & Thornburg LLP
  • USA
  • March 30 2015

The FDA recently issued a final guidance document titled, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."


FDA issues draft guidance on medical device accessories
  • Barnes & Thornburg LLP
  • USA
  • February 2 2015

The Food and Drug Administration (FDA) recently issued a draft guidance document titled, "Medical Device Accessories: Defining Accessories and