Hyman Phelps McNamara

By Kurt R. Karst –      As you enter the Courtroom 402 “dance hall” at the U.S. Court of Appeals for the Federal Circuit on Wednesday, June 3, 2015, you’ll have to decide whether to take an initial right step and join the Amgen Inc. …

By Allyson B. Mullen – On April 22, 2015, FDA released a draft guidance regarding use of clinical data generated outside of the U.S. (OUS) in medical device premarket submissions.  A copy of the draft guidance can be found here.  FDA states in the guidance that it …

By David C. Gibbons – On Tuesday, April 21, 2015, the U.S. Department of Health and Human Services Health Resources and Services Administration (“HRSA”) issued a Notice soliciting comments on its proposal to collect pricing data from drug manufacturers under the 340B drug discount program.  This …

By Riëtte van Laack – As we previously reported, the U.S. Court of Appeals for the D.C. Circuit issued a decision in what some have identified as a landmark advertising case of the Federal Trade Commission (FTC) against POM Wonderful et al. (POM).  On April 6, …

By James E. Valentine* & Josephine M. Torrente – During FDA’s April 1, 2015 public workshop on clinical outcome assessments (COAs), in a presentation on the future of COA development and utilization in drug development programs, officials from CDER’s Study Endpoints and Labeling Development (SEALD) staff …

By Riëtte van Laack – On April 9, 2015, US Right to Know (USRTK, Petitioner) filed a Citizen Petition (CP) with FDA and sent a letter to the Federal Trade Commission (FTC) requesting action against what USRTK claims is false and misleading use of the term …

By David B. Clissold – In September 2011, the Center for Tobacco Products (“CTP”) issued a draft guidance entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (“Draft Guidance”).  In the Draft Guidance, the Food and Drug Administration (“FDA”) claimed …

By Allyson B. Mullen & Jeff N. Gibbs – As we have previously blogged on numerous times (for example, here and here), FDA has released a framework for regulation of laboratory developed tests (LDTs).  FDA’s proposed framework has sparked much controversy, receiving support from diagnostic test …

By Allyson B. Mullen – On April 13, CDRH released the final guidance document for “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.”  We previously blogged on the draft guidance …

By Riëtte van Laack – In an effort to stop the implementation of the National Organic Program’s (NOP’s) interpretation of the sunset review process, a coalition of organic “stakeholders” have filed a lawsuit in the U.S. District Court for Northern California.  The lawsuit alleges that the …

By Jay W. Cormier –  It has been quite some time since the September 2010 Veterinary Medicine Advisory Committee (“VMAC”) meeting that discussed FDA’s review of AquaBounty’s AquAdvantage Salmon application.  Earlier this month, Food and Water Watch – a long-time and very vocal opponent to the …

By Riëtte van Laack – On April 9, 2015, FDA published a proposal to amend the regulations regarding registration of food facilities.  The proposal addresses a multitude of issues: codification of certain self-implementing provisions of the Food Safety Modernization Act 0f 2011 (FSMA), amendment of the …

By Kurt R. Karst –       Some days we feel like the “Dickie V” (Dick Vitale) of the Hatch-Waxman and Biosimilars worlds – enthusiastically calling play-by-play on litigation and other FDA happenings, just like the Basketball Hall of Fame broadcaster does for college basketball games.  (And while …

By Kurt R. Karst –       It’s not all that often that we see the Patent and Trademark Office (“PTO”) dismiss or deny a request to extend the term of a patent covering a medical device, though such actions on a Patent Term Extension (“PTE”) request do …

By Alexander J. Varond – After six years of operating under its May 2009 “Guidance for Industry: Formal Meetings Between the FDA and Sponsors of Applicants,” FDA refreshed its guidance.  On March 11, FDA announced its draft guidance entitled “Formal Meetings Between the Food and Drug Administration and …