FDA staffing exodus degrading oversight

Departures of experienced FDA managers, reviewers and administrative staff are slowing interactions with the agency and eroding the quality of guidance for early- and mid-stage development programs, a trend hitting smaller biotechs hardest, according to eight leaders of companies and institutions with programs in the clinic.

Those concerns were echoed by consultants and attorneys representing scores of companies with active development programs. Most sources requested anonymity, fearing that speaking publicly could jeopardize current or future FDA interactions...