Position Paper on Accelerated Approval for INVIRASE Brand Saquinavir
by Mark Harrington 7 November 1995 In September, 1994, the Treatment Action Group spelled out the following conditions as necessary for our support of an accelerated NDA for an HIV protease inhibitor: Adequate and well-controlled clinical endpoints studies are well…
TAG Does ICAAC
AIDS Research Highlights from the 35th Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC) September 1995 by Mark Harrington and Michael Marco with Spencer Cox and Tim Horn From the Introduction The 35th ICAAC was a more interesting conference than…
FDA Regulation of Anti-HIV Drugs: A Historical Perspective
August 1995 By Spencer Cox Edited by Mark Harrington & Bruce Schackman From the Executive Summary Over the period in which FDA has reviewed and regulated anti-HIV therapies, there has been a substantial decline in the quality and quantity of…
The Lymphoma Project Report
Current Issues in Research and Treatment of AIDS-Associated Lymphoma by Michael Marco May 1995 From the Introduction Lymphomas are not new. They pre-date AIDS for many many years. We have known for some time that organ transplant patients and others…
Problems With Protease Inhibitor Development Plans
February 1995 By David Barr, Spencer Cox, Gregg Gonsalves, Mark Harrington, Derek Link, Michael Ravitch & Theo Smart Edited by Mark Harrington for the National Task Force on AIDS Drug Development From the Introduction The development of protease inhibitors offers…
Rescuing Accelerated Approval: Moving Beyond the Status Quo
A Report to the FDA Antiviral Drugs Advisory Committee By Spencer Cox, Dennis Davidson, Gregg Gonsalves, Mark Harrington, Carlton Hogan, Rebecca Pringle Smith 12-13 September 1994 Silver Spring, Maryland Moving Beyond the Status Quo: A Statement of Principles on AIDS…
The KS Project Report
Current Issues in Research & Treatment of Kaposi's Sarcoma by Michael Marco with Martin Majchrowicz July 25, 1994 From the Introduction In October 1993, the National Institute of Allergy and Infectious Diseases (NIAID) published its HIV/AIDS Research Agenda . Only…
Letter to David Kessler, US FDA
Dear Commissioner Kessler: We're writing with reference to FDA’s plans to regulate the development of a new class of anti- HIV therapies known as “protease inhibitors,” and with specific reference to possible regulatory decisions regarding Hoffmann-LaRoche, Inc.’s Ro 31-8959 (“saquinavir”).