Ramnarayan Randad
Food and Drug Administration, USA
Title: Regulatory requirements and filling considerations for type II master files
Biography
Biography: Ramnarayan Randad
Abstract
A Type II Master File or Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. 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, an Export Application, or amendments and supplements to any of these. On July 9, 2012, the Food and Drug Administration’s Safety and Innovation Act (FDASIA) was signed into law (Public Law No. 112-144, 126 Stat. 993, 2012). This law, among other, establishes new requirements for Type II DMF’s. This ppresentation will discuss on regulatory requirements and filling considerations for Type II DMFs with US FDA.