Sally Gu

Sally Gu

Hogan Lovells

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“Advancing Real-World Evidence Program” offers drug sponsors early FDA meeting opportunity

FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more

11/7/2022  /  Biologics , Biosimilars , Disclosure Requirements , Food and Drug Administration (FDA) , Prescription Drugs , User Fees
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