Supplements and other changes to an approved NDA
| Currency | Current through May 31, 2023 |
| Citation | 21 C.F.R. §314.70 |
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Section 5 Food and Drug Administration
- United States
- The Missouri Bar Farm Law Deskbook Chapter 11 Selected Biotechnology Issues
- Invalid date
...new methods of producing existing drugs. The FDA requires new applications for drugs that are either new or produced from a new source. 21 C.F.R. § 314.70. Generally, the FDA will require new drug applications for most drugs manufactured using biotechnology. 51 Fed. Reg. 23,009 (June 24, 19......