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Four key observations on the nomination of Robert…
It’s official: Former FDA Commissioner Robert Califf is President Biden’s choice to be the next Commissioner of the FDA. But what would his appointment mean for the FDA, and how should regulatory professionals think about the selection?
FDA Forecast: What’s Next for the FDA in…
Join AgencyIQ’s regulatory intelligence team as we explore the top regulatory issues we expect the FDA and life sciences industry to grapple with in 2022, including what we expect to happen, why, and what it would mean for the industry.
Generic drug data show steady year-over-year trends in…
New data reported by the FDA’s Office of Generic Drugs show consistency in the number of generic applications the FDA refused to receive and the number of first cycle approvals, though the data do show some important and subtle changes, too.
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50+
Years of Combined Regulatory Experience
9
Areas of Research Focus
Pharmaceuticals
Biologics
Advanced Therapies
Medical Devices
Diagnostics
Dietary Supplements
Blood Products
Generics/Biosimilars
OTC products
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