ARTICLE | Clinical News

Epitope Inc regulatory update

December 20, 1993 8:00 AM UTC

EPT said it has received a warning letter from the FDA alleging that the company is violating the Federal Food, Drug and Cosmetic Act in regard to promotional activity for OraSure, EPT's oral specimen collection device to detect HIV. OraSure is awaiting FDA approval. Company spokesperson Mary Hagen described the letter as "a routine warning letter. They told us it will not interfere with the approval process." ...