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Results: 1-10 of 8,127

FDA Approves Prickless Glucose Monitoring System
  • Knobbe Martens
  • USA
  • January 23 2018

The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients


Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • January 22 2018

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust


FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products
  • Jones Day
  • USA
  • January 22 2018

FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided


Washington Healthcare Update - Jan 22, 2018
  • McGuireWoods LLP
  • USA
  • January 22 2018

The House passed a spending measure that funds the government until the middle of February. The bill includes a six-year extension of CHIP, a


FDA Announces Plans for Alternative Clearance Pathway
  • Knobbe Martens
  • USA
  • January 22 2018

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance


Medtronic Pain Management Device Approved by FDA
  • Knobbe Martens
  • USA
  • January 22 2018

Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According


FDA Pre-cert Program for Lab-Developed Tests
  • Knobbe Martens
  • USA
  • January 22 2018

The FDA may begin certifying the laboratories that produce lab-developed tests ("LDTs") instead of drafting regulatory rules to cover the tests


First-Ever De Novo Clearance by FDA’s Orthopedic Branch
  • Knobbe Martens
  • USA
  • January 21 2018

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s


FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)
  • Hogan Lovells
  • USA
  • January 19 2018

The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable


NDAANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book
  • Mintz Levin
  • USA
  • January 18 2018

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have