U.S. FOOD AND DRUG ADMINISTRATION: The Breakthrough Therapy Designation
For two decades, CDER has used certain methods to speed drug development and the regulatory review process so that promising therapies can get to patients faster.
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U.S. FOOD AND DRUG ADMINISTRATION: Drug Shortages
Drug shortages have a significant impact on both hospitals and patients.
U.S. FOOD AND DRUG ADMINISTRATION: State of CDER 2019
An audio podcast series featuring the Director of FDA Center for Drug Evaluation and Research