Hyman Phelps and McNamara
Firm Publications
  DOJ Uses False Claims Act to Enforce FDA Manufacturing Rules  April 7, 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
  A Practical Roadmap for Transitioning State Licenses for Sales of Prescription Drugs and Devices in Corporate Transactions  November, 2016
  Ninth Circuit Confounds Practice of Medicine and Off-Label Use Issues  November 1, 2016
  Promoting Your 510(k) - Pending Device: 5 Questions About FDA's Policy  October 12, 2016
  A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification Is More Than a Regulatory Violation  September 7, 2016
  Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay  September 2016
  FDA Seeks Methods to Better Regulate NGS Products  September, 2016
  Assessing the FDA's Safety Drive  August 1, 2016
  Devices May Be Over-the-Hill, but Regulatory Developments and Challenges Show No Signs of Slowing Down  July 12, 2016
  Top Food and Drug Cases 2015 and Cases to Watch 2016: United States v. Quality Egg, LLC  2016
  Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future? The Short Answer: No  April 2016
  Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation  April 2011
  Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products  March 31 2016
  HPM/KPMG Webinar: A Practical Guide to the MDRP Final Rule  February 19, 2016
  Summary of MDRP Final Rule  February 01, 2016
  FDA and Product Jurisdiction: Time for Reforms  February 1, 2016
  Commercialisation of Healthcare Global Guide  January 19, 2016
  A Matter of Substantial Discretion: A Recent Rift between DEA and Its ALJs Could Significantly Impact Registrants  November/December 2015
  Amarin Case Tests Limits of FDA Regulation of Off-Label Promotion  October 1, 2015
  Thomas Reuters Commercialisation of Healthcare  October 1, 2015
  Summary of HRSA 340B Proposed Guidance  September 3, 2015
  Outcome of LDT Regulation Controversy Defies Forecasting  July 21, 2015
  Room for Flexibility in FDA's "Gold Standard" of Drug Approval  July 16, 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

Show more firm publications