Cassandra Rasmussen

Cassandra Rasmussen

King & Spalding

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Latest Posts › Food and Drug Administration (FDA)

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A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

11/10/2021  /  21st Century Cures Act , Data Collection , Drug Approvals , EHR , Food and Drug Administration (FDA) , Medical Devices , New Guidance , Pharmaceutical Industry , Prescription Drugs , Real World Evidence

EUROPE – Are Revisions of the Orphan Drug Regulation and Adoption of a Regulation on “Unmet Medical Needs” on the Horizon

The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more

9/11/2020  /  EU , European Commission , European Medicines Agency (EMA) , Fast Track Process , Food and Drug Administration (FDA) , Funding , Medical Reimbursement , Orphan Drugs , Proposed Regulation
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