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U.S. Food and Drug Administration Kicks Off Fall with Several Impactful Medical Product Guidances | Wilson Sonsini Goodrich & Rosati

The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics. ....

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FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
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FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

The FDA is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing late-phase product development issues. ....

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Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence

Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence ....

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