1. Title 21. Food and Drugs. Chapter I. Food and Drug Administration. Subchapter D. Drugs for human use. Part 314. Applications for FDA approval to market a new drug. 21 CFR 314.94(a)(3);Code of Federal Regulations,2011
2. Title 21. Food and Drugs. Chapter I. Food and Drug Administration. Subchapter D. Drugs for human use. Part 314. Applications for FDA approval to market a new drug. 21 CFR 314.94(a);Code of Federal Regulations,2011
3. Title 21. Food and Drugs. Chapter I. Food and Drug Administration. Subchapter D. Drugs for human use. Part 314. Applications for FDA approval to market a new drug. 21 CFR 314.94(a)(9)(iii);Code of Federal Regulations,2011
4. Title 21. Food and Drugs. Chapter I. Food and Drug Administration. Subchapter D. Drugs for human use. Part 314. Applications for FDA approval to market a new drug. 21 CFR 314.94(a)(9);Code of Federal Regulations,2011
5. Title 21. Food and Drugs. Chapter I. Food and Drug Administration. Subchapter D. Drugs for human use. Part 314. Applications for FDA approval to market a new drug. 21 CFR 314.94(a)(9)(i) [citing 21 CFR 314.50(d)(1)];Code of Federal Regulations,2011