In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 4 ( 2018-02-13), p. 9-17
Abstract:
A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or amendments and supplements to any of these.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v3i4.172
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2018
detail.hit.zdb_id:
2738279-5
SSG:
15,3
