Christina Markus

Christina Markus

King & Spalding

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FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

7/14/2025  /  Capital Markets , Compliance , Disclosure Requirements , Drug Approvals , Food and Drug Administration (FDA) , Investors , Pharmaceutical Industry , Regulatory Requirements , Securities Litigation , Shareholders

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
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