Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 2020
Strengthening its Track Record of Successful Client Regulatory Approval Outcomes
SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--#FDA--Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)
i, and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe.