What Are The Contents Of An Nda Application?

1.	What Are The Contents Of An Nda Application?
Answer» Detailed reports of pre-clinical studies Detailed reports of clinical studies INFORMATION on composition and manufacture of the drug and on controls and facilities used in manufacture Samples of drug and its labeling Full case reports of the persons who received the drug, needed only in LIMITED circumstances Patient information MATERIAL previously submitted to FDA in the IND application or in periodic reports MUST be included by REFERENCE in the NDA

Answer»

Detailed reports of pre-clinical studies
Detailed reports of clinical studies
INFORMATION on composition and manufacture of the drug and on controls and facilities used in manufacture
Samples of drug and its labeling
Full case reports of the persons who received the drug, needed only in LIMITED circumstances
Patient information
MATERIAL previously submitted to FDA in the IND application or in periodic reports MUST be included by REFERENCE in the NDA

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