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Abstract

In 1984, the 505(b)(2) application route for a New Drug Application was created by Congress to allow applicants to create innovative medicines using currently available products without performing a full complement of safety and efficacy studies. This article reviews the history of the approach, provides examples, and considers some of the scientific and technical challenges associated with documenting safety and efficacy relative to the proposed change. The approach does not appear to have been used extensively in the almost 18 years since it was created. The explanation for this is not fully apparent, but may relate to the limited exclusivity, usually three years, allowed for a 505(b)(2) application.

Keywords

Waxman-Hatch 505(b)(2)Pharmaceutical equivalence Bioequivalence Listed drug Patent certification

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References

21 U.S.C. 355(b)(2).

Sasinowski

Scarlett

Reliance on phantom ANDAs to access NDA data. Reg Affairs. 1991;3:467–482.

US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance: Applications Covered by Section 505(b)(2). Rockville, MD: US Food and Drug Administration, Center for Drug Evaluation and Research: October 1999. http://www.fda.gov/cder/guidance/2853dft.htm.

FDA Public Docket No. 99D-4809, Pharmaceutical Research and Manufacturers of America, April 3, 2000.

Morgan, Lewis & Bockius Citizen Petition, FDA's Docket Management Branch, July 27, 2001.

US Food and Drug Administration, Center for Drug and Biologics Evaluation and Research. Guidance: Providing Evidence of Effectiveness for Human Drug and Biologic Products. Rockville, MD: US Food and Drug Administration, Center for Drug and Biologics Evaluation and Research. May 1998. http://www.fda.gov/cder/guidance/1397fnl.pdf.

US Food and Drug Administration. Guidance: FDA's Policy Statement for the Development of New Stereoisomeric Drugs. Rockville, MD: US Food and Drug Administration; May 1992. http://www.fda.gov/cder/guidance/stereo.htm.

505(b)(2) Applications: History,Science,and Experience *

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