Abstract

DYNAMICS OF DRUG MASTER FILINGS AT UNITED STATES FOOD AND DRUG ADMINISTRATION

Narender Kumar* and Vikaas Budhwaar

ABSTRACT

Drug Master File came into being on March 10, 1943 with the submission of documentation for Lathane to support its application pursuant to section 505 (b) of the FDCA. Drug Master filing at USFDA in one of the parameters that helps in knowing the potentiality of a country in the field of pharmaceuticals. Filing a drug master file at USFDA implies that the company is claiming manufacturing drug and facility suitable for USFDA rules and regulations. Several incidences are available where a company do have a USFDA approved facility but do not have financial viability of the developed products. The article mainly concentrates statistics relating to type II drug master filing at USFDA since manufacturing drugs in USFDA approved facilities usually comply with global standards.

Keywords: Drug Master File, Holder, Intellectual property, Regulatory status.