When the FDA resolved legal hurdles to the 505(b)(2) approval pathway in 2003, providing a practical alternative route for drug development, Ken Phelps and Ruth Stevens founded Camargo Pharmaceutical Services to help companies gain approval under 505(b)(2). Camargo will be celebrating both events in booth 410 at the DIA Annual Meeting in Boston, June 23-27.
 
“FDA approvals under 505(b)(2) have risen every year since 2003 because it offers a faster and less costly process that permits developers to minimize risk and often still receive patent protection,” said Mr. Phelps. “2012 was another record year, with 47 505(b)(2) drug approvals in all, 50% more than the number approved under 505(b)(1).”
 
“Since the 505(b)(2) pathway became viable, it has rendered significant changes on the drug development landscape,” said Ms. Stevens. “Today, companies around the world are using 505(b)(2) to gain entry into the U.S. market, and a similar development pathway is being implemented in the E.U. and elsewhere. This is an important and increasingly complex area of drug development, and we’re here to help clients sort it out.”