FDA warned Intarcia about manufacturing issues before drug rejection

Less than two months before the FDA rejected Intarcia Therapeutics ’ potential blockbuster treatment for type 2 diabetes last year, inspectors at the agency faulted the Boston-based company for a litany of manufacturing issues and warned about potential drug contamination, a newly-obtained document shows. The document, a manufacturing warning letter known as a F orm 483, offers new clues about why the FDA declined to approve Intarcia’s drug in September 2017. Since that time, the company has said…
Source: bizjournals.com Health Care News Headlines - Category: Health Management Authors: Source Type: news