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Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers companies publicly traded in the U.S. facing upcoming PDUFA dates.
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FDA Tracker. Analytics for Pharma and Biotech Traders....
- Trial Tracker
Trial Tracker Demo. This limited demo only displays Phase 3...
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Vertical Format: Click here for a high-resolution, printable PDF (3.9 MB) of the infographic. Drug Review Steps Simplified. Preclinical (animal) testing. An investigational new drug application...
• Changes to accommodate expedited review of applications in the PDUFA V Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs (the Program) – September 2014
Get daily updates on important FDA approval, PDUFA dates, and FDA Advisory Committee Meetings with RTTNews FDA Calendar & Upcoming Approvals.
FDA Calendar. Our Free FDA Calendar is a daily updated tool that tracks future catalysts and key dates across biotech and pharma companies, including clinical trials, regulatory events, and PDUFA dates, designed to inform on stock-moving events
A New Drug Application (NDA) tells the full story of a drug. Its purpose is to demonstrate that a drug is safe and effective for its intended use in the population studied. A drug developer...
Purpose of an NDA. Enables FDA to determine: Whether the drug is safe and effective for the proposed indication, and whether the drug’s benefits outweigh the risks. Whether the drug’s proposed labeling is appropriate, and what should be included in the package insert.
