FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 3 - Control of the Drug Product and Stability - Pharmaceutical Technology

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FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 3 - Control of the Drug Product and Stability
Chemistry reviewers in the FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs

Pharmaceutical Technology
Volume 35, Issue 2, pp. 58-67


1. A. Srinivasan and R. Iser, Pharm. Technol. 34 (1), 50–59 (2010).

2. A. Srinivasan, R. Iser, and D. Gill, Pharm. Technol. 34 (8), 45–51 (2010).

3. ICH, Q6A, Federal Register: 65(251) (Dec. 29, 2000).

4. FDA, QbR Frequently Asked Questions (June 4, 2007).

5. ICH, Q3B Impurities in New Drug Products (R2) (Geneva, July 2006)

6. FDA, OGD, Guidance for Industry, ANDAs: Impurities in Drug Products (draft) (Rockville, MD, August 2005).

7. EMA, Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products for Human Use (CHMP) (Doc. Ref EMEA/CHMP/QWP/251344/2006), Jan. 1, 2007.

8. FDA, Guidance for Industry, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (draft) (Rockville, MD, December 2008).

9. FDA, Development of New Stereoisomeric Drugs (Rockville, MD, 1992).

10. FDA, "21 CFR 211 cGMPs for Finished Pharmaceuticals" [Testing and Release for Distribution, Sec. 211.165 (a)], revised Apr. 1, 2010.

11. FDA, Guidance for Industry, Orally Disintegrating Tablets (Rockville, MD, December 2008).

12. FDA, MAPP 5223.2, Scoring Configuration of Generic Drug Products (Rockville, MD, Nov. 1, 1995).

13. British Pharmacopeia, Formulated Preparations: General Monographs—Tablets Volume III, Ph. Eur. monograph 0478 (2010).

14. USP Stimuli Article, Pharmacopeial Standards for the Subdivision Characteristics of Scored Tablets, Pharmacopeial Forum 35 (6) (Rockville, MD, Nov–December 2009).

15. B. Snider, P. Liang, and N. Pearson, Pharm. Technol. 31 (2), 56–71, (2007).

16. USP 33–NF 28 (USP, Rockville, MD, 2010).

17. "21 CFR 314 Applications for FDA Approval to Market a New Drug," [Content and Format of an Abbreviated New Drug Application, Sec. 314.94 (9)], revised Apr. 1, 2010.

18. A. Gupta, V.A. Sayeed, and M.A. Khan, "The Science and Regulatory Perspectives of Pharmaceutical Suspensions," in Pharmaceutical Suspensions, From Formulation Development to Manufacturing, Eds. A.K. Kulshreshtha, O.N. Singh, G.M. Wall (Springer, New York-Dordrecht -Heidelberg-London, 2010), pp. 265–284.

19. S. Vaithiyalingam et al., Internat. Jrnl. of Pharmaceut. 398 (1–2) 2010

20. M. Wokovich et al., Euro. Jrnl. of Phrm. and Biophrm. 64 (1), 1–8 (2006).

21. FDA, Guidance for Industry, Residual Drug in Transdermal and Related Drug Delivery Systems (draft) (Rockville, MD, August 2009).

22. N. Sadrieh, B. Michniak-Kohn, and R. Harapanhalli, presentation at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, Aug. 5, 2009, Topic 2, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/ucm178925.htm.

23. ICH, Q1A(R2) Stability Testing of New Drug Substances/Products (2003).

24. ICH, Q1B Photostability of New Drug Substances and Products (1996).

This article represents the views of the authors and not of FDA.


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