CONCEPT OF 505 (b) (2) APPLICATION: BENEFITS AND CHALLENGES

  • Chaitanya Prasad K.
  • Prabodh M.
  • Ashish S.
  • Suthakaran R

Abstract

A 505(b) (2) application is a new drug application (NDA) delineated in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.505(b)(2) application is one that one or a lot of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant and has not obtained a right of reference or use from the person by or for whom the investigations were conducted. Section 505(b) (2) was added to FFDC Act by the Drug price competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). The applicant will depend on either revealed literature or agency’s findings of an antecedent approved drug. This approval route was designed to encourage innovation and to eliminate expensive and long duplicative clinical studies.

Keywords: ANDA; Clinical Trials; CFR; Exclusivity; FFDC Act; Hatch Waxman Act; 505 (b) (1); NDA; NME.

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References

1. Klasmeier C, Cope T. U. S. Department of Health and Human Services. NDA Approval Under FDCA Section 505(b)(1): Food and Drug Administration Centre for Drug Evaluation and Research (CDER) 2013 July.
2. US FDA. Guidance for Industry Applications Covered by Section 505(b)(2) [Internet]. U. S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) 1999 Oct [Cited 2014 May 27]; Available from: www.fda.gov/downloads/Drugs/ Guidances/ucm079345.pdf
3. Lauren S S, Pharm. D. Assistant clinical professor, School of Pharmacy. Understanding the 505(b)(2) approval process. University of Connecticut; 2006 Aug.
4. Code of Federal Regulations 21, the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register [Internet]. 1998 Apr [Cited 2014 May 27]; Available from: www.gpo.gov/fdsys/pkg/CFR-2000-title21-vol1/content-detail.html
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http://www.accessdata.fda.gov/scripts/cder/drugsatfda.
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How to Cite
K., C. P., P. M., A. S., and S. R. “CONCEPT OF 505 (b) (2) APPLICATION: BENEFITS AND CHALLENGES”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 2, Feb. 2018, pp. 16-20, doi:10.22270/ijdra.v2i2.127.

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