FDAapproval95% confidence
Prescription Drug User Fee Amendments
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to PROD DEVELOPMENT; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
Supporting Context
- Therapeutic area
- Neurology · Antiepileptic
- Sub-indication
- General
Related signal: FDA Grants Approval for Lacosamide ANDA217596