Search Results for: andrew wasson

FDA Lawyers Blog is pleased to announce that Andrew S. Wason, Partner, in our New York office is a key presenter at the Food and Drug Law Institute’s (“FDLI’s”) Intellectual Property Throughout the Drug Development Lifecycle: Opportunities and Challenges Conference in Washington, D.C. on July 17, 2012. FDLI’s new Conference will address the intellectual property […]

“Revisiting the Debate on an Orange Book for the Biologics Price Competition and Innovation Act” by Andrew S. Wasson was published in the latest edition of FDLI Update. In comparing the Biologics Price Competition and Innovation Act (“BPCIA”) to the Hatch-Waxman Amendments, commentators are quick to point out that the laws differ in many ways. […]

FDLI Policy Forum Vol 1, Issue 4 “Should FDA Undertake More Than a ‘Ministerial’ Role With Respect to Patent Information?” by Brian Malkin and Andrew S. Wasson can be found in FDLI’s current Food and Drug Policy Forum. For many years FDA has argued that it lacks the resources and expertise to review patents substantively. […]

Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009 Brian J. Malkin and Andrew S. Wasson wrote an article appearing in the January/February 2011 Food Drug and Law Institute Update titled “Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009.” The article tests the hypothesis whether the Biologics Price […]

FDA Lawyers Blog is pleased to report that Andrew S. Wasson, Partner, in our New York office was a presenter at the Food and Drug Law Institute’s (“FDLI’s”) “Intellectual Property Throughout the Drug Development Lifecycle: Opportunities and Challenges” Conference in Washington, D.C. on July 17. This Conference addressed intellectual property (“IP”) issues important to patent […]

 Attorneys at FLH have actively followed the development of biosimilars legislation and have written on the topic in a number of forums. Some of our publications include: Brian J. Malkin, Challenges to the Development of a Biosimilars Industry in the United States, Recent Developments in Food and Drug Law, Aspatore / Thompson Reuters (2013 Edition) […]

Editors: Charles J. Raubicheck Andrew S. Wasson Authors: Caroline Bercier Laura A. Chubb Leann M. Clymer Benjamin I, Dach, Ph.D. Laura Fanelli Russell A. Garman, Ph.D. Christopher Gosselin Blaine Hackman, Ph.D. Michael W. Harkness Jason A, Kanter Richard F. Kurz Erin A. Lawrence Alyse P. Mauro1 Rachael P. McClure Kate Mead3 Elizabeth Murphy Eric Nielson3 […]

FDA issued a draft guidance on March 18, 2014 titled, “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations.” This draft guidance seeks to revise and update FDA’s March 2003 guidance titled, “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations.” This document provided guidance for NDAs, INDs, and […]

Johnson and Johnson (“J&J”) recently joined the discordant chorus of stakeholders and commentators who have weighed in on the issue of naming for biosimilar products. On the one hand, some advocate for shared International Non-Proprietary Naming (“INN”) system names between a biologic approved under Section 351(k) of the Biologics Price Competition and Innovation Act of […]

23andMe, the Google-backed direct-to-consumer genetic testing provider, has suspended its health-related genetic testing in response to FDA’s November 22, 2013 Warning Letter. In the Warning Letter, FDA directed 23andMe to “immediately discontinue marketing [its Saliva Collection Kit and Personal Genome Service, “PGS”] until such time as it receives FDA marketing authorization for the device.” While […]