Executives Share Strategies for Successful Dealings With FDA on Product Submissions

SAN FRANCISCO—Communication and good strategy are the keys to successful dealings with Food and Drug Administration, executives with experience in biotechnology regulation said April 7.

Companies need to be on the same page as the FDA. And the key to that is communication, from the investigational new drug application throughout the life cycle, said Jason Rock, chief technical officer for GlobalSubmit Inc., a company based in Philadelphia.

“And a lot of times you’re going to have to present your case every step of the way,” Rock told a session at a conference sponsored by the biotechnology trade group BayBio.

Efficiency ...