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Center for Biologics Evaluation and Research (CBER) FDA Warning Letters Biologics

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 3 of 3)

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more

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

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