Hyman Phelps and McNamara
 
Firm Publications
 
  Court deals blow to mysteriously named whistleblower, blowing off precedent  October 17, 2017
  When it comes to software as a medical device, FDA acknowledges that new technology no longer fits the old regulatory paradigm  September 19, 2017
  Is the 510(k) process as worthless as the federal courts seem to believe?  August 8, 2017
  The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials  July 27, 2017
  Congress Seeks a Statutory Fix to Stymied Off-Label Discussions  May 2, 2017
  DOJ Uses False Claims Act to Enforce FDA Manufacturing Rules  April 7, 2017
  LDTs: The Saga Continues  April 2017
  The Problem of the ‘Intended Use’ Regulations Continues to Fester  March 21, 2017
  A Phoenix Rising from The Ashes: FDA Proposes a Rule Requiring Submission of Device Labels and Package Inserts  November 29, 2016
 


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