FDA-TRACK: Center for Drug Evaluation and Research Index
A-Z Index
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
CDER Dashboards | |
Accelerated Approval | |
Actions General (PDUFA) | |
Actions General (BsUFA) | |
Actions General (GDUFA) | |
Actions – Approval (PDUFA) | |
Actions – Approval (BSUFA) | |
Actions – Approval (GDUFA) | |
Actions – Tentative Approval | |
Actions – CRs | |
Actions within Goal Dates | |
Advisory Committee Meetings | |
ANDAs | |
ANDA First Cycle Approvals | |
Biosimilar BLAs | |
Biosimilar Development Programs Enrolled in the BPD Program | |
Breakthrough Therapy Designations | |
Commercial INDs (Drugs) | |
Commercial INDs (Biosimilars) | |
Conference Presentations | |
DSCs | |
Drug Shortages | |
Editorials | |
Efficacy Supplement | |
FAERS Reports by Seriousness | |
Fast Track Designations | |
First Cycle Performance (GDUFA) | |
First Cycle Performance Adjusted for Imminent Approval or Tentative Approval (GDUFA) | |
First Generics | |
Guidance Documents | |
Journal Articles | |
Meetings under BsUFA (including Biosimilar Initial Advisory Meeting, BPD Type 1 Meeting, BPD Type 2 Meeting, BPD Type 2a Meeting, BPD Type 2b Meeting, BPD Type 3 Meeting and BPD Type 4 Meeting) | |
Meetings under PDUFA (including Type A Meeting, Type B Meeting, Type B (EOP) Meeting, Type C Meeting, Type D Meeting, and Type INTERACT Meeting, and WRO) | |
NDAs | |
Newly Approved REMS | |
Non-Biosimilar BLAs | |
Novel Drug Approvals | |
Original Supplements for Category E and F | |
PAS Applications | |
Post-CRs (Meetings and Letters) | |
Priority Review Determination | |
Published Letters | |
Rare Disease Approvals (including Accelerated Approvals, Breakthrough Therapy Designations, Fast Track Designations, NDA Approvals and Tentative Approvals, Non-Biosimilar BLA Approvals and Tentative Approvals, Novel Drug Approvals, Priority and Standard Review Determination) | |
Recall Events and Unique Products Recalled (including Class 1 Recalls, Class 2 Recalls, and Class 3 Recalls) | |
Regulatory and Other Actions for Pharmacy Compounders and Outsourcing Facilities | |
Regulatory Publications | |
REMS Assessments Submitted | |
REMS Modifications Approved | |
REMS Released | |
Review and Scientific Articles | |
SrLCs | |
Shared System REMS | |
Standard Review Determination | |
Supplements with Clinical Data | |
Total Publications | |