Guideline: BACPAC I: (withdrawn) Intermediates in Drug Substance Synthesis, Bulk Actives Post-approval Changes: Chemistry, Manufacturing and Controls Documentation
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| Titel: | BACPAC I: (withdrawn) Intermediates in Drug Substance Synthesis, Bulk Actives Post-approval Changes: Chemistry, Manufacturing and Controls Documentation |
| Herkunft/Verlag: | 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 |
| Inhalt: | Diese Guideline der FDA behandelt Post Approval Changes bei Wirkstoffen |
| Status: | withdrawn |
| Dokumentenart: | FDA Guidance |
