FDA Perspectives: Designation of Regulatory Starting Materials in the Manufacturing of Drug Substances: Impact on ANDA Review Time - Pharmaceutical Technology

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FDA Perspectives: Designation of Regulatory Starting Materials in the Manufacturing of Drug Substances: Impact on ANDA Review Time
The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application.

Pharmaceutical Technology
Volume 36, Issue 1, pp. 63-66


1. R. Giralt, "A New Definition for API Starting Materials," Pharmaceutical Technology Europe 16 (6), 2004.

2. ICH, Q11: Development and Manufacture of Drug Substances (ICH, May 2011).

3. ICH Q9, Quality Risk Management (ICH, June 2006). This is directly applicable to the drug product manufacture but also applies the risk-based thinking with regard to the drug substance.

4. Muller et al., "A Rationale for Determining, Testing, and Controlling Specific Impurities in Pharmaceuticals that Possess Potential for Genotoxicity," Regulatory Toxicology and Pharmacology 44, 198–211, (2006).

5. A. Thayer, "Genotoxic Impurities," C&E News Sept. 2010, 88 (39), pp. 16–26.

6. FDA, Draft Guidance for Industry: Fermentation Derived Intermediates, Drug Substances, and Related Drug Products (FDA, Dec. 2002)

7. S. Schaeffer, "Equivalence Test Case," Biocentury 18 (34), A1–A7 (2010).

8. ICH, Q8(R2) "Quality Target Product Profile" definition; see also Spring 2011 GPHA Meeting Slides by R. Lionberger; Yu, Pharm. Res. 25 781–791, 2008.


The views and opinions in this article are only those of the author and do not necessarily reflect the views or policies of the US Food and Drug Administration.


The author thanks Naiqi Ya, Dave Skanchy, Bob Iser, and Aloka Srinivasan for their scientific input.

Barbara Scott is a chemistry and manufacturing reviewer (CMC) at the Office of Generic Drugs within the Office of Pharmaceutical Science, under the US Food and Drug Administration's Center for Drug Evaluation and Research,


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