|
|
The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
|
|
| NDAs: Impurities in Drug Substances (Feb. 2000) |
| Internet: | http://www.fda.gov/cder/guidance/3622fnl.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance/ |
| Content: | Guideline issued by CDER (FDA) on necessary identification and qualification for NDAs and drug master files of impurities in active substances manufactured by chemical synthesis (monographed and non-monographed drug substances) |
| Document Type: | Guidance for industry |
|
|
|
|
|
