The 505(b)(2) New Drug Application

Abstract

It has been more that 20 years since the 505(b)(2) application route for a New Drug Application was created by Congress to encourage innovation in drug development without requiring the conduct of expensive, time-consuming studies that demonstrate already-known qualities about a drug. Although the use of this approach was not frequently employed by sponsors in the many years it has been available, the awareness of the provision has been heightened and some of the mystery surrounding its interpretation lessened by the issuance of a draft Guidance for Industry entitled “Applications Covered by Section 505(b)(2)” in October 1999 by the Food and Drug Administration. This approach has significant strategic advantages, given the right situation, and should be an important consideration when determining a regulatory strategy to employ in developing new dosage forms or other modifications to previously approved active pharmaceutical ingredients. In addition, even if your company is primarily focused on new chemical entity development, keep abreast of the advantages and disadvantages of this approach to better understand potential strategies being considered by your competitors.