The 505(b)(2) New Drug Application
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The 505 (b)(2)New Drug Application
J. Chrirtopher Prue, RPL, MBA Regulatory Affairs, Purdue Pharma LP, Stamford. Connecticut Arthur J. Mayorgo,
RPL, PhD Johnson 6 Johnson Pharmaceutical Research and Development. Titusville. New Jersey
Key Words 505(b)(2): Exclusivity; New Dtug Application; Strategy; Submission Correspondence Address J. Christopher Prue. RPh. MBA. Vice President. Regulatory Affairs and Pharmacovigilance. Atherogenics. Inc., 8995 Westside Parkway, Alpharetta. Georgia (e-mail: [email protected]).
It has been more that 20 years since the SoS(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the provision has been heightened and some of the mystery surrounding its interpretation lessened by the issuance of a draft Guidance for Industry entitled "ApplicationsCovered by
INTRO D UCTlO N A 505(b)(2) is a New Drug Application (NDA) involving an active pharmaceutical ingredient (API) that relies on, in part, a previous finding of safety and effectiveness for that API by the Food and Drug Administration (FDA). This submission option was added to the federal Food, Drug, and Cosmetic Act through the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). Although this regulatory pathway has existed for more than 2 0 years, 505(b)(2) applications were relatively uncommon until the last seven or eight years, possibly because, until recently, there was not a clear understanding of the types of submissions that could use this approach. To clarify this topic, the FDA issued a draft Guidance for Industry entitled "Applications Covered by Section 505(b)(2)" for public comment in October 1999. This guidance clarifies the information given in section 505(b)(2) of the federal Food, Drug, and Cosmetic Act and provides examples of the types of applications that can use this option.
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 ifyour 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.
requires is contained within the application or the applicant has a full right to refer to it. For a 505(b)(2) application, all or part of the information submitted could come from studies not conducted by or for the sponsor company and for which the sponsor company has not obtained a right of referenc
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