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Supreme Court Denies Defense Request to Review Key FCA Materiality Decision After Government Offers to Dismiss Claims
  • Arent Fox LLP
  • USA
  • January 16 2019

On January 7, the US Supreme Court declined to review United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), leaving in


What the Government Shutdown Means for Imports
  • Arent Fox LLP
  • USA
  • January 2 2019

The US Government has been under a partial shutdown since December 21, 2018, and it is anyone’s guess when the shutdown will end. Congress has


FDA Doubles Down on Medical Device Program
  • Arent Fox LLP
  • USA
  • December 21 2018

FDA has been establishing policies to benefit new programs for the medical device industry, including opportunities in the Digital Health arena and


FDA and USDA Split the Cell-Cultured Burger
  • Arent Fox LLP
  • USA
  • November 26 2018

The jurisdictional skirmish over the regulation of cell-cultured meat products appears to have been resolved with the recent announcement by the Food


FDA Provides Relief to Medical Device Manufacturers Under UDI
  • Arent Fox LLP
  • USA
  • November 8 2018

The FDA has delayed the date on which it plans to enforce compliance with certain Unique Device Identification (UDI) requirements, prompting a


HHS Proposes Disclosure of Drug Prices in TV Advertising, But Fight Over Authority On the Horizon
  • Arent Fox LLP
  • USA
  • October 29 2018

The Department of Health and Human Services (HHS) has issued a proposed rule (PR) which would require any television advertisement for a drug or


FDA Targets Sales of E-Cigarette Manufacturer Juul to Minors in Surprise Inspection
  • Arent Fox LLP
  • USA
  • October 8 2018

According to reports, two FDA inspectors, at times joined by a third official, arrived the morning of September 24 to Juul’s San Francisco office and


FDA is Getting Ready for Its Close-up on Labels
  • Arent Fox LLP
  • USA
  • August 24 2018

Through a series of recent statements, FDA Commissioner Scott Gottlieb has signaled that the agency is prepared to assert its enforcement authority


USDA and FDA Initiate Processes to Revise Regulation of Agricultural Biotechnology
  • Arent Fox LLP
  • USA
  • July 13 2018

The United States Department of Agriculture and the Food and Drug Administration have recently initiated processes to evaluate and propose revisions


FDA Issues Guidances for Shared REMS and Waivers to Help Promote Competition and Access
  • Arent Fox LLP
  • USA
  • July 11 2018

On May 31, 2018, the FDA announced two new guidances designed to help generic drug manufacturers to obtain access to shared Risk Evaluation and