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U.S. Food and Drug Administration

U.S. Food and Drug Administration

Federal Regulatory Agency

Appears in 2 stories

Stories

The Six-Month Cure: Gene Editing Goes Bespoke

The Six-Month Cure: Gene Editing Goes Bespoke

Developing joint CDER-CBER guidance on plausible mechanism pathway

New Capabilities dormant
Lab-Grown Brain Tissue Cracks the Psychiatric Diagnosis Problem

Lab-Grown Brain Tissue Cracks the Psychiatric Diagnosis Problem

Regulates psychiatric drug approvals; eliminated clozapine REMS program

New Capabilities ongoing