FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 2: Description, Composition, and Excipients - Pharmaceutical Technology

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FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 2: Description, Composition, and Excipients
FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.

Pharmaceutical Technology
Volume 34, Issue 8, pp. 45-51


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

2. FDA, Inactive Ingredient Search for Approved Drug Products, http://www.accessdata.fda.gov/scripts/cder/iig/, accessed June 30, 2010.

3. FDA, Guidance for Industry: Immediate Release Dosage Forms, Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (SUPAC-IR) (Rockville, MD, Nov. 1995).

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

5. FDA, Guidance for Industry: Submitting Documentation for the Manufacturing of and Controls for Drug Products (Rockville, MD, Feb. 1987).

6. FDA, Data Standards Manual (monographs), Dosage Form, CDER Data Element Number, C-DRG-00201 (Dec. 15, 2006)

7. FDA, "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)].

8. FDA, "Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)"

9. FDA, Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (Rockville, MD, May 18, 2005).

10. FDA, "21 CFR 73 Listing of Color Additives Exempt from Certification", [Synthetic Iron Oxide, Sec. 73.1200].

11. S. Borodkin and M. H. Yunker, Jrnl. of Pharma. Sci. 59 (4) 481-386 (1970).

12. R. C. Rowe, P.J. Shesky, and M. E. Quinn, Eds., Handbook of Pharmaceutical Excipients, 6th ed. (Pharmaceutical Press, July 31, 2009).

13. USP 32–NF 27 (USP, Rockville, MD, 2010).

14. FDA, "21 CFR 170 Food Additives–21 CFR 180 Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study."

15. Food and Chemicals Codex 6 (USP, Rockville, MD, 2010).

16. IPEC-Americas, Excipient Master File Guide (Arlington, VA, 2004).

17. FDA, "21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceutical," [Testing and Approval or Rejection of Components, Drug Product Containers, and Closures, Sec. 211.84 (d) (2)].

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


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