“Emerging Sponsors” Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA’s Jenkins Says

08 Dec 2011

Office of New Drugs director says the agency is seeing more small, inexperienced companies traveling the drug development and approval pathway on their own. However, these firms need more advice from the agency and are all too eager to publicly share their one-sided view about these regulatory interactions.

The growing trend of “emerging sponsors” taking drugs through the development and approval process on their own is creating regulatory and public relations challenges for FDA, according to one of the agency’s senior drug review officials.

Speaking at the FDA/CMS Summit on Dec. 8, Office of New Drugs Director John Jenkins said small and often venture-backed...