News & Analysis as of

Center for Biologics Evaluation and Research (CBER) Investigational New Drug Application (IND) Coronavirus/COVID-19

Mintz - Health Care Viewpoints

Update on FDA’s Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from...

As we discussed in our last update on the Food and Drug Administration’s Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will...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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