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FDA programs encourage and expedite drug development and approval

The Orphan Drug Act of 1983 has created incentives for the development of drugs and biologics for rare diseases. Last month, the Wall Street Journal examined the acts effects on patients, healthcare costs, and the biotech industry, pointing out:

Nearly half of all products produced by biotech companies are for orphan diseases.

Two of the larges......

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Tax credits for clinical testing
Waived application user fees
Seven years market exclusivity if the product is the first orphan of that type approved for marketing

The programs market exclusivity provisions are what make orphan products such a lucrative niche. They prohibit the FDA from approving another drug or biologic with the......

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Accelerated Approval is a newer program that has proven to be more attractive to eligible sponsors. It is available for products for serious or life-threatening illnesses that provide a meaningful therapeutic benefit over existing treatments. Meaningful therapeutic benefit can include an ability to treat patients unresponsi......

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Priority Review is intended for products that address unmet medical needs. Products generally must provide a significant improvement compared to marketed products for a particular disease. The benefit of the program is clear: The FDA has a six-month review goal for Priority Review applications after a complete application is filed, whereas a regular application has a 10- ......

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'"/> By Patricia Kaeding 12/14/05

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