The FDA's 505(b)(2) approval pathway, which allows modification and repositioning of existing drugs for expeditious marketing clearance, is highly used by biotech and pharmaceutical companies. However, 505 (b)(1) for molecular entities and 505(j) for abbreviated new drug applications also are available. Understanding the differences and choosing the right pathway is vital. In a BioWorld Today audio conference, Ken Phelps, founder of Camargo Pharmaceutical Services, will share his expertise in the 505(b)(2) regulatory approval pathway and in influencing successful FDA approval of numerous drug products.

"The FDA's 505(b)(2) Drug Approval Process: How to Navigate the Pathway" is just $349 per listening site. Scheduled for Jan. 28 from 2-3:30 p.m. EST, it includes handouts and a half-hour Q&A session with the speaker. A conference CD (MP3 format) also is available. For information or to register, call 800-688-2421 or 404-262-5474. Mention conference code T08485.