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, 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 [...]
505(b)(2) - Freedom from Generic Competition - Exclusivity Issues
Published October 28th, 2007 in 505(b)(2) Issues. 0 CommentsWell, freedom from generic competition for a while at least. Generally, most companies business plans specify some means to keep the competition at bay until the product can make a profit : when revenues start to exceed investments.
There are two ways for 505(b)(2) applications to obtain a market free from a duplicate: patent protection and exclusivity. [...]
Last week’s Drug Repositioning Summit was attended by more than 150 people. The Summit started with my 3-hour workshop on 505(b)(2) drug development. Several attendees were seemingly confused about what “drug repositioning” means. There are two distinct ‘flavors’ of drug repositioning:
Take a currently US-approved drug and make significant changes to it (formulation, dose, route of [...]
Maybe the title should have a question mark after it - will the review time for a first generic drop? FDA plans to do so - it announced the Generic Initiative for Value and Efficiency (GIVE). Basically, the Office of Generic Drugs will try to review within 6 months an application for a first generic [...]
