Breaking News: FDA Expands IZERVAY™ Label for Long-Term Use in Geographic Atrophy Management
1. What’s New? The U.S. Food and Drug Administration has approved an expanded prescribing label for IZERVAY™, enabling unlimited duration dosing in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) Astellas Pharma US, Inc. | News Room. Previously, treatment duration was capped at 12 months. 2. Clinical Evidence Behind the Expansion This […]
Data required to be submitted by an applicant for conduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength
Requirements for drug approval with new claims
In case a drug already approved by the Central Licencing Authority for certain claims, which is now proposed to be clinically tried or marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration or novel drug delivery system (NDDS), the requirements of data and information […]