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FDA Releases Final Guidance on Drug and Medical Product Communications with Payors and Others
  • FisherBroyles LLP
  • USA
  • June 15 2018

Earlier this week, the U.S. Food and Drug Administration (FDA) issued two new final guidance documents that provide greater clarity regarding the


FDA Issues Final Guidance Documents Relating to Medical Product Manufacturer Communications
  • Ropes & Gray LLP
  • USA
  • June 15 2018

On June 12, 2018, the Food and Drug Administration (“FDA”) issued two key documents outlining the agency’s current thinking regarding drug and device


FDA Releases Guidance on Dietary Fiber
  • Keller and Heckman LLP
  • USA
  • June 15 2018

Today, June 15, 2018, FDA published in the Federal Register a notice that it has issued “Guidance for Industry: The Declaration of Certain Isolated or


Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers
  • Hogan Lovells
  • USA
  • June 15 2018

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes


FDA Releases Guidance on Evaluating Animal Drug Safety in Food-Producing Animals
  • Keller and Heckman LLP
  • USA
  • June 14 2018

FDA’s Center for Veterinary Medicine (CVM) has released a new guidance document (Guidance for Industry 3: General Principles for Evaluating the Human


FDA Finalizes Two Guidance Documents Regarding Medical Product Communications
  • Cooley LLP
  • USA
  • June 13 2018

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer


APHIS Changes Import Permit Policy for Medical Devices Containing Animal Derived Ingredients
  • Arent Fox LLP
  • USA
  • June 13 2018

Medical devices containing animal derived ingredients that have been approved by the Food and Drug Administration now may enter the US without the


FDA Updates Master Class: Forecasting Agency Food Labeling Priorities
  • Perkins Coie LLP
  • USA
  • June 12 2018

As the FDA continues to work towards the mission of ensuring the safety of food and beverage products for US consumers, through oversight and action


PMA Preemption Win At Summary Judgment Stage
  • Dechert LLP
  • USA
  • June 12 2018

What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a


Bipartisan Bill Would Protect State Marijuana Laws
  • Keller and Heckman LLP
  • USA
  • June 12 2018

Several U.S. Senators introduced a bipartisan bill titled, Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act), on June 7