This article was originally published in The Gray Sheet
Files additional materials with FDA in support of the company's premarket approval application for OraSure, an oral specimen collection device for use in detection of antibodies for HIV-1. The filing, which the firm submitted in response to concerns raised at a Dec. 18 FDA blood products advisory committee meeting ("The Gray Sheet" Dec. 21, 1992, p. 5) and subsequent sessions with FDA staff, "covers proposed labeling, a mechanism for confirmation of positive screening tests, procedures for subject counseling, and training of specimen collection personnel," according to Adolph Ferro, Epitope president and chief executive officer.
You may also be interested in...
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.
In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.
Duo will study up to four novel preclinical targets identified by Sitryx that may lead to potential new drugs for autoimmune diseases, which Lilly would then commercialize.