Our process for developing a drug product to be submitted to the US FDA under the 505(b)(2) process has been validated during many meetings with FDA. I want to share important aspects of this process with the community.
This is the first post of several parts. I will use the following flow diagram as our road map. [...]
Archive for October 30th, 2007
505(b)(2) - Part 1: The overall process
Published October 30th, 2007 in 505(b)(2) Process. 0 CommentsAdams Respiratory Therapeutics announced that it received an Approvable letter from FDA on 10/29/07 for its guaifenesin 600/1200 mg and codeine phosphate 30/60 mg extended-release bi-layer tablets. The release indicates that the FDA needed additional data to support the use of the product with food.
The proposed product is one of several currently on the market that [...]
