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Washington Healthcare Update - Dec 4, 2017
  • McGuireWoods LLP
  • USA
  • December 4 2017

Testifying before the House Energy and Commerce Committee on implementation of the 21st Century Cures Act on Nov. 30, FDA Commissioner Scott Gottlieb


FDA Releases Stem Cell Guidance Documents
  • Foley & Lardner LLP
  • USA
  • November 27 2017

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing


FDA Publishes Supplemental Guidance on Menu Labeling for Chain Restaurants
  • McDermott Will & Emery
  • USA
  • November 20 2017

On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu


Washington Healthcare Update - Nov 13, 2017
  • McGuireWoods LLP
  • USA
  • November 13 2017

Republicans are considering repealing the mandate that currently requires that most Americans obtain health coverage. The Republican House-proposed


Will FDA Be Forced To Eat Menu Labeling?
  • Venable LLP
  • USA
  • November 9 2017

The Affordable Care Act (ACA) gave our nation "Obamacare." The ACA also gave the FDA the obligation to adopt regulations requiring "a restaurant or


Menu Labeling Update: FDA Releases Supplemental Draft Guidance
  • Keller and Heckman LLP
  • USA
  • November 8 2017

Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by


CMS Revises Medicare Part B Biosimilar Coding and Payment Policies
  • Covington & Burling LLP
  • USA
  • November 8 2017

On November 1 and 2, 2017, the Centers for Medicare & Medicaid Services ("CMS") released two final rules addressing changes to Medicare Part B


Washington Healthcare Update - Oct 30, 2017
  • McGuireWoods LLP
  • USA
  • October 30 2017

Rep. Elijah Cummings (D-MD) and Sen. Bernie Sanders (I-VT) introduced legislation on Oct. 25 to let the government negotiate drug prices in Medicare


Sanofi Files Suit Against Merck Sharp & Dohme Over Second NDA for Insulin Glargine Biologic: A Look at the Differences in Biosimilar Approval Pathways
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • October 19 2017

On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of New Jersey


NYC to Defer to the FDA in Calorie Posting Rules
  • Cole Schotz PC
  • USA
  • October 16 2017

As New Yorkers enjoy their pumpkin spice lattes, the fact that a Grande (16oz) serving will cost them about 380 calories (including 2 milk and