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FDA Launches ‘Quik’ 510(k) Review Pilot Program
  • Knobbe Martens
  • USA
  • October 11 2018

The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to

Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 6 2018

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal

New York Attorney General Announces Settlements with Three Mobile Health Application Developers
  • Jones Day
  • USA
  • May 12 2017

New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney

New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs of Concern are Heard in mHealth App World
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • April 5 2017

In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman

FDA Issues Draft Guidance on Biosimilar Interchangeability
  • Latham & Watkins LLP
  • USA
  • January 27 2017

On January 18, 2017, the US Food and Drug Administration (FDA or Agency) issued its highly anticipated draft guidance on demonstrating

FDA Continues FSMA Implementation, Finalizes Guidance on Voluntary Qualified Importer Program to Expedite Food Imports
  • Kelley Drye & Warren LLP
  • USA
  • November 18 2016

The Food & Drug Administration (FDA) released last week a final version of its guidance for industry on the Voluntary Qualified Importer Program

FDA Final Rule Implementing and Amending Regulations regarding Title XI of Medicare Prescription Drug, Improvement, and Modernization Act (“MMA”) of 2003
  • Fitzpatrick, Cella, Harper & Scinto
  • USA
  • October 21 2016

On October 6, 2016, FDA published a Final Rule in the Federal Register to implement and amend certain regulations regarding the MMA. These changes

Biosimilar FDA Approvals on the Horizon As More States Enact Substitution Laws
  • Mintz
  • USA
  • August 30 2016

In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA's Arthritis Advisory Committee (AAC) voted

FDA Reaches Agreement with Industry for Reauthorization of Medical Device User Fees
  • Knobbe Martens
  • USA
  • August 30 2016

The Food and Drug Administration has issued a statement announcing that the FDA and representatives from the medical device industry and laboratory

DEA Denies Marijuana Rescheduling Petition, Eases Research Restrictions
  • Arent Fox LLP
  • USA
  • August 16 2016

Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of