FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
FDA Rationale for Recognition Decision: Isavuconazonium sulfate
FDA Rationale for Recognition Decision: Isavuconazonium sulfate
Guidance Documents for Drug Applications
Guidance documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of…
Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting – 09/24/2025
The Food and Drug Administration (FDA) is holding a hybrid public meeting titled “Prescription Drug User Fee Act and Biosimilar…
First Generic Drug Approvals
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides…
Division of Oncology 2 (DO2)
The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications…
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments – 09/30/2025
On September 30, 2025 FDA will hold its annual public meeting and opportunity for public comment on Financial Transparency and…
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments | 2021 – 06/28/2021
This public meeting is intended to meet performance commitments included in PDUFA VI, BsUFA II, and GDUFA II.
CDER Guidance Agenda
CDER Guidance Agenda