News & Analysis as of

Department of Health and Human Services (HHS) › Center for Biologics Evaluation and Research (CBER)

Venable LLP

CBER Director Resigns from FDA, Commissioner Makary’s Recent Remarks on FDA Staffing Cuts, CBER Hiring Data, and Additional...

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more

King & Spalding

FDA Publishes White Paper on Artificial Intelligence & Medical Products

King & Spalding on

On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more

King & Spalding

Accelerated Covid-19 Vaccine Clinical Trials

King & Spalding on

Liability exposure and shields for vaccine developers - As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more

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