Policy Statement on NDA 20-993, Gilead Sciences, Inc's Application for Approval of Preveon™ adefovir dipivoxil for Treatment of HIV 1 November 1999 New York, NY Introduction On June 29th, 1999, Gilead Sciences, Inc. submitted new drug application (NDA) 20-993 to…
August 1999 From the Executive Summary From 30 July to 1 August 1999, a diverse, internation al group of biomedical researchers, statisticians, clinicians, research administrators and community treatment advocates met to discuss and develop plans for research on structured treatment…
February 19, 1999 Introduction If one should hear yawns emanating from the consecrated halls of the Food and Drug Administration (FDA), it's possible that the team evaluating the New Drug Application (NDA) for Agenerase™ brand amprenavir is responsible. The HIV…
by Mark Harrington 19 September 1998 Late every August, the once-and-future greats (and some not-so greats) of AIDS research pay pilgrimage to HIV co-discoverer Robert C. Gallo at the annual laboratory meeting once, in palmier days, hosted in Bethesda by…
A Critical Review of New Antiretroviral Drugs & Treatment Strategies June 1998 By Spencer Cox, Jill Cadman, Paul Dietz, Mark Harrington, Winston Layne, Luis Santiago & Theo Smart Introduction by Spencer Cox In January, 1996, at the Third Conference on…
AIDS Related Opportunistic Infections Report (Version 2.0) By Michael Marco, Steve Kass, Paul Dietz, Laura Morrison, Theo Smart, Evan Wilder, Tim Horn and Mark Harrington February 1998 From the Introduction Six years ago, at the Amsterdam AIDS Conference, I joined…
Maximal HIV Suppression becomes the Goal of Antiretroviral Therapy Unequal Access to Care Still Hinders Treatment Advances Members of the Treatment Action Group (TAG), a non-profit AIDS research and treatment advocacy group in New York City, offered strong praise for…