Understanding the FDA 505(b)(2) Regulatory Approval Pathway
Understanding FDA 505(b)(2) Let us consider for a moment the why a drug development organization would follow the FDA 505(b)(2) regulatory approval pathway as opposed to the 505(b)(1) approval pathway and how the two differ.
What are these two entities? Both are regulatory pathways pertaining to a new drug application (NDA).
The FDA 505(b)(1) process is what the industry is familiar with and 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.
These are two different regulatory approaches and processes leading to drug applications and approvals.
The drug repositioning process is where pharma takes drugs that failed clinical programs and make changes in the endpoints of their studies or make changes to the molecule itself in order to get approval.
This is clearly different than the 505(b)(2) process.
Don't be confused as following the wrong process could result in a RTF (Refusal to File) or worse yet, actions that could be taken by FDA.
In the economic and competitive climate of today, I strongly suggest that pharma consider the 505(b)(2) process, whenever and wherever it's appropriate, for getting drugs approved and to the market as cost effectively as possible
What are these two entities? Both are regulatory pathways pertaining to a new drug application (NDA).
The FDA 505(b)(1) process is what the industry is familiar with and 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.
These are two different regulatory approaches and processes leading to drug applications and approvals.
The drug repositioning process is where pharma takes drugs that failed clinical programs and make changes in the endpoints of their studies or make changes to the molecule itself in order to get approval.
This is clearly different than the 505(b)(2) process.
Don't be confused as following the wrong process could result in a RTF (Refusal to File) or worse yet, actions that could be taken by FDA.
In the economic and competitive climate of today, I strongly suggest that pharma consider the 505(b)(2) process, whenever and wherever it's appropriate, for getting drugs approved and to the market as cost effectively as possible
