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
  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

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