The commercial life of a drug and the sales trajectory achieved are dependent on a multitude of factors. One critical factor in achieving success is the ability to bring a product to market quickly to gain competitive advantages and to start recouping development costs. From product concept to market, there are a number of potential areas of opportunity for accelerating a drug through to FDA approval. Many initiatives tie to scientific and technological innovations in the research and development realm while others are tied to the regulatory pathway.
The four main FDA mechanisms that can play a role in speeding drugs to market are Accelerated Approval, Priority Review, Fast Track and orphan designation. All of these were designed with the intention of facilitating development of drugs that address critical needs.
The focus of the report, “Accelerating Drugs to Market”, is to provide insights & analysis on the regulatory mechanisms currently in place and how they may add value to drug manufacturers in their pursuit to accelerate products to market.
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Scope
- Background, benefits and regulations related to accelerated approval
- Overview of related policies and programs
- Key takeaways and considerations
Key Reasons to Purchase
- Access a full analysis of the key FDA/Regulatory mechanisms in place to support a company’s ability to accelerate a drug to market
- Gain invaluable insights into the differences that exist between the 4 key FDA mechanisms and which one is most appropriate for you
- Understand where the similarities & differences exist between the US and EU programs to support a synergistic approach to product development
- Review actual statistics which provide insights into whether or not these mechanisms truly provide a faster way to get a drug to market in the US
- Identify where the overlap exists between Accelerated Approval, Priority Review, Fast Track, and Orphan Drug Designation to support the most effective & efficient product development approach and revenue generation opportunity
Table Of Contents
Executive Summary
Introduction
Where are there opportunities to influence how quickly a drug reaches the market?
Accelerated Approval
Background on the regulation
Benefits and risks to manufacturers
EU regulation: Conditional Marketing Authorization
Priority Review
Background on the policy
Impact on drug approval times
Priority Review Vouchers
EU regulation: Accelerated Assessment
Fast Track
Background on the program
Influence on drug development & approval timelines
Considerations for manufacturers
Orphan Drug Designation
Background on the regulation
Advantages and risks in orphan drug development
EU regulation: Orphan Designation
Key Takeaways & Considerations
Appendix
List Of Table
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List Of Figures
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