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IND-Enabling Studies

An active Investigational New Drug (IND) application is required by the U.S. Food and Drug Administration (FDA) before human studies may be conducted. For new drugs and even most follow-on…

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What are Adaptive Design Clinical Trials?

Adaptive clinical trial designs have been used extensively in medical device development, and lessons learned are now being applied to drug development. Adaptive design can reduce the number of patients…

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5 Common FDA Applications for Drugs & Biologics

There are two broad application categories for drugs and biologics regulated by the United States Food and Drug Administration (FDA): requests for authorization for clinical investigations requests for marketing approval…

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