Not too long ago, filing a new drug application with the US Food and Drug Administration could mean sending four 48-foot trucks stuffed with 100,000 pages of documentation off to the agency's headquarters in Rockville, Md. "I saw several of those get hauled away from loading docks," says Nathaniel Brown, speaking of his years as global clinical development leader for lamivudine at Glaxo.
But for Brown, now chief medical officer and executive vice president of clinical development for Idenix, those days are gone. The Cambridge, Mass.-based startup has planned since its inception to file electronically with the FDA for approval of its hepatitis B drug telbuvidine. By the end of this year, the company will send off two CD-ROMs with its complete new drug application (NDA). They'll be walked into the FDA's central document room, signed for, and the agency will let them know by E-mail that the document has ...
