Hyman Phelps and McNamara
Firm Publications
  Amarin Case Tests Limits of FDA Regulation of Off-Label Promotion  October 1, 2015
  Summary of HRSA 340B Proposed Guidance  September 3, 2015
  Outcome of LDT Regulation Controversy Defies Forecasting  July 21, 2015
  Meet the Attorney, HD Insights: A Huntington disease research periodical, vol. 11, Spring 2015 Edition  June 1, 2015
  Quality Egg and Jail Time for a Park Doctrine Prosecution  May 6, 2015
  Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Update, July 2010 to June 2014, Therapeutic Innovation & Regulatory Science  April 27, 2015
  Bringing Your Pharmaceutical Drug to Market  April 1, 2015
  A Warning Letter on FDA's Expansive Interpretation of Its Facilities - Inspection Authority  March 13, 2015
  Prior Restraint and the Union Political Spech Opt-Out Requirements  March 1, 2015
  Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy Practitioners  February 28, 2015
  Exploring the FDA's Flexibility With Novel Orphan Therapies, Neurological Rare Disease Special Report, Supplement to Neurology Reviews  February 1, 2015
  510(k) Statistical Patterns  December 2, 2014
  Unearthing Mansfield's Rule: Analysing the Appropriateness of Federal Rule of Evidence 606(B) in Light of the Common Law Tradtition  December 1, 2014
  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
  4 Regulatory Challenges Facing IVD Companies Today  May 12, 2014
  How to Effectively Use FDA's Presubmission Process  May 12, 2014
  FDA and LDTs  April 9, 2014
  Complete or Partial Accommodation: An Analysis of the Federal Circuit Split Over the Duty of the Employer to Reasonably Accommodate the Religious  April 1, 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

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