Case Study 50 : Pre-NDA meeting with FDA for 505(b)(2)

Company Situation

The Client is a US based manufacturer of pharmaceutical products who had developed a new formulation for Metformin tablets with modified drug delivery technology. Client needed to understand the possibility of submitting NDA to US FDA using the 505 (b) 2 pathway in order to minimize development time and cost.

GRP Solution

GRP has significant experience in obtaining FDA approvals using 505 (b)2 pathway for drugs with new formulations, combination drugs, new indications and new delivery technologies.  GRP engaged with Client to identify a suitable strategy for registration using FDA’s 505(b)(2) pathway based on available information. The entire project was executed three phases as outlined below.

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