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FDA Expedited Pathways Guidance Expands Range Of Eligible Products

 
• By Sue Sutter

Drugs intended to prevent a serious condition or reduce likelihood of disease progression may qualify, as may products intended to diminish serious adverse events associated with current treatment.

FDA’s final guidance on expedited programs expands the types of drugs that could qualify for the special regulatory pathways and provides additional clarity around how “available therapy” will be determined.

However, the agency stands by its timeframe laid out in a draft guidance for deciding what constitutes U.S

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More from North America

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