Understanding 505(b)(2) and Why

Let us consider for a moment the 505(b)(2) regulatory approval pathway, why you should use it and how it differs from 505(b)(1). What are these two entities? Both are regulatory pathways pertaining to a new drug application (NDA).

The 505(b)(1) process is what the industry is familiar with - this process is used by pharma for new drugs that are new discoveries, new chemical and biologic entities.
The 505(b)(2) process takes drugs that have already been approved and makes small modifications to them often allowed by FDA for significantly advancing patient safety and benefit.
Now, more than ever, the 505(b)(2) process should be used by pharma in times of economic stress and when we are faced with reduced budgets, reduced R&D and shorten timelines.

* The 505(b)(2) process is relatively low risk because the drug has already been proven to be safe.
* It is low cost because there are fewer studies.
* It is also faster due to fewer studies, and if done right, a drug can make it to market in as little as 3 years.

In the economic and competitive climate of today, I strongly suggest that pharma consider the 505(b)(2) process for getting drugs approved and to the market.