FDALabel

FDALabel aggregates over 140,000 human prescription, biological, over-the-counter (OTC), and animal drug labeling documents to enable quantitative analysis of FDA orphan drug designations and therapeutic trends for diseases such as glioblastoma (GBM).

Key Features:

• Extensive Database: Contains over 140,000 human prescription, biological, OTC, and animal drug labeling documents.
• Customizable Searches: Supports customizable search and retrieval across the indexed labeling documents for targeted data extraction.
• Regulatory Insights: Indexes FDA orphan drug designation information, including approved, withdrawn, and designated compounds.

Scientific Applications:

• Orphan Drug Designation Analysis: Provides quantitative insights into FDA orphan drug designations for compounds intended to treat glioblastoma (GBM), including approved and withdrawn designations and emerging therapeutic mechanisms.
• Trend Analysis: Enables temporal analyses of therapeutic trends, such as shifts from cytotoxic drugs to immunotherapies and small molecules.
• Clinical-Regulatory Research: Facilitates cross-sectional assessment of the drug-development landscape for GBM, covering designations from 1983 to 2020.

Methodology:

Quantitative cross-sectional analysis of orphan drug designations from 1983 to 2020, conducted in accordance with STROBE criteria.