Hyman Phelps and McNamara
 
Firm Publications
 
  Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay  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
  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
  Putting Together the Pieces: Recent Proposals to Fill in the Genetic Testing Regulatory Puzzle  Spring, 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
  The Regulatory Landscape for Hospice and Home Health Providers Continues to Change  January , 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
 


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