1 publication

• Published Subscription 3 May 2019

  Drug Master File—Electronic Submission through eCTD: An Overview

  By Y. Patel, A. Pathan

  Abstract: A Drug Master File (DMF) is a supporting document for various applications such as Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologic License Application (BLA), etc. Mainly product’s chemistry, manufacturing, and control (CMC) part is covered in the DMF. As per the current guidelines of US Food & Drug Administration (USFDA), all types of DMFs are mandatory to be submitted through Electronic Common …

  Published in Trends in Drug Delivery · Vol. 6, Issue 1, 2019 · pp. 8–13 Read article →