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Results:1-10 of 81

Enforcement Date & Notable Differences In FDA’s Final Guidance For Menu Labeling
  • Locke Lord LLP
  • USA
  • May 12 2016

On May 5, 2016, FDA published a Notice of Availability (NOA) of its Final Guidance on menu labeling, entitled "Guidance for Industry: A Labeling


A Stay of Litigation Pending IPR Does Not Provide a Basis For Extending 30-Stay of FDA ANDA Approval
  • Locke Lord LLP
  • USA
  • January 12 2016

On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation


What does “natural” mean to you? FDA solicits comments & information on use of the term on food labels as it considers rulemaking
  • Locke Lord LLP
  • USA
  • November 12 2015

Amid growing ambiguity due to the spread of consumer litigation and the beginnings of patchwork state legislation, the FDA is finally taking action


FDA issues draft guidance on stem cell same surgery exception
  • Locke Lord LLP
  • USA
  • November 11 2014

On October 23, 2014, the FDA's Center for Biologics Evaluation and Research issued draft guidance for tissue establishments and healthcare


FDA: industry must address cybersecurity risks for medical devices.
  • Locke Lord LLP
  • USA
  • October 3 2014

On October 1, 2014 the U.S. Food and Drug Administration finalized guidance on recommendations to manufacturers for managing cybersecurity risks to


FDA releases guidance on mobile medical applications
  • Locke Lord LLP
  • USA
  • October 8 2013

On September 25, 2013, the U.S. Food and Drug Administration ("FDA") released final guidance on how it intends to regulate mobile applications


Attention pharmaceutical and medical device executives ignorance is not bliss
  • Locke Lord LLP
  • USA
  • October 31 2012

The recent sentencings of a number of executives on so-called "Park pleas" serve as an important reminder that the United States Department of Justice, working with the Food and Drug Administration, holds managers, officers, and in-house counsel at drug and medical device companies to a high standard with respect to overseeing the safe manufacture and delivery of drugs and medical devices to consumers.


FDA sets initial fees and deadlines for andas and related submissions under GDUFA
  • Locke Lord LLP
  • USA
  • October 25 2012

On July 9, 2012, Congress passed the Generic Drug User Fee Amendments (“GDUFA”), Public Law 112-144, Title III, in response to the backlog of abbreviated new drug applications (“ANDAs”) awaiting FDA review.


Government addressing pharmaceutical and medical device manufacturing practices
  • Locke Lord LLP
  • USA
  • October 4 2012

Over-shadowed by record-breaking resolutions relating to off-label marketing has been the government turning to address pharmaceutical and medical device companies’ improper manufacturing practices through criminal investigations.


Congressional update: FDA user feedefense spendingtransportation
  • Locke Lord LLP
  • USA
  • May 29 2012

With the Republican primary all but settled, Congress has approximately three months a very narrow window of time to resolve a host of issues before adjourning for the November election.