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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


FDA’s Approval of First Cannabis-Derived Drug Breaks New Ground, Met with Mixed Reactions
  • Arent Fox LLP
  • USA
  • July 5 2018

Last week, the Food and Drug Administration approved the first cannabis-derived drug, Epidiolex, for the treatment of two rare forms of epilepsy


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 Proposes New Class II Device Marketing Pathway
  • Arent Fox LLP
  • USA
  • April 17 2018

The Expanded Abbreviated 510(k) Program could offer a quicker path to market for class II devices, with the potential for clearance decisions to


In Rare Move, FDA Debars Company from Importing Food
  • Arent Fox LLP
  • USA
  • March 15 2018

For the first time in recent history, the Food and Drug Administration has debarred a foreign firm from importing food into the United States. The


FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer
  • Arent Fox LLP
  • USA
  • March 14 2018

On March 6, 2018, the US Food and Drug Administration issued an authorization letter to 23andMe, Inc. that permits marketing of the company’s genetic


FDA Ramps Up Transparency Initiative but Still Exploring Whether to Include CR Letters
  • Arent Fox LLP
  • USA
  • January 24 2018

On January 16, 2018, FDA Commissioner Scott Gottlieb, M.D., delivered a presentation, “Fostering Transparency to Improve Public Health” to the John