Hyman Phelps and McNamara
 
Firm Publications
 
  GEN LDT Article-New LDT Guidance Documents Face Scrutiny  November 7, 2014
  Hyman, Phelps & McNamara jointly with Barton and Blank present the webinar: Medical Device Promotion on Social Media  October 21, 2014
  FDA's Move to Regulate LDTs Could Reshape the Industry  September 19, 2014
  Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices  September 12, 2014
  FDA Announces Intention to Regulate LDTs as Devices  August 7, 2014
  Significant Settlements, Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014  January 2014
  How to Effectively Use FDA's Presubmission Process  May 12, 2014
  4 Regulatory Challenges Facing IVD Companies Today  May 12, 2014
  FDA and LDTs  April 9, 2014
  Examining Hot Button Areas for FDA & Related Government Enforcement  February 12, 2014
  The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?  February 4, 2014
  Application of Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices  January 5, 2014
  Thomson Reuters Book: Commercialisation of Health Care  November 4, 2013
  Trends in Personalized Medicine  October 2013
  The Long and Winding Road to FDA Regulation of LDTs  October 2013
  What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions  September 2, 2013
  Draft Guidance on Medical Device Recalls: Improvements Are Needed  July / August 2013
  How, and When, Will FDA Regulate LDTs?  July 15, 2013
  New Paper Argues 510(k) Program Has Strengths That Critics Have Overlooked  April 22, 2013
  The US FDA and its Draft Guidance on Medical Device Appeals  April 2013
  Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations  February 2013
  Summary of CMS Final Rule on Transparency Reporting  February 12, 2013
  Should DEA Provide Guidance & Conduct Rulemaking on Suspicious Orders to Ensure Balanced Approach to Reduce Abuse & Ensure Avail. of Needed Medicine?  January, 2013
  FDASIA's Impact on Novel IVDs  October 1, 2012
 


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