This article highlights the challenges that FDA’s Office of Generic Drugs now faces, following the abrupt departure of its director at a time of tremendous change under GDUFA. Catalyst’s Nancy Bradish Myers comments on CDER Director Woodcock’s reversal of her plans to oversee the office herself during the search for a permanent Director, and the subsequent appointment of long-time FDA official Kathleen Uhl as Acting Director.
Growing Pains for Generic Drugs: OGD Gains Respect, But Loses Geba
The RPM Report
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