FDA-TRACK: Center for Drug Evaluation and Research Index

 

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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

A	CDER Dashboards
Accelerated Approval	Drugs and Biologics Dashboard
Actions General (PDUFA)	Drugs and Biologics Dashboard
Actions General (BsUFA)	Biosimilars Dashboard
Actions General (GDUFA)	Generics Dashboard
Actions – Approval (PDUFA)	Drugs and Biologics Dashboard
Actions – Approval (BSUFA)	Biosimilars Dashboard
Actions – Approval (GDUFA)	Generics Dashboard
Actions – Tentative Approval	Drugs and Biologics Dashboard Generics Dashboard
Actions – CRs	Generics Dashboard
Actions within Goal Dates	Drugs and Biologics Dashboard Biosimilars Dashboard Generics Dashboard
Advisory Committee Meetings	Policy and Science Development Dashboard
ANDAs	Generics Dashboard
ANDA First Cycle Approvals	Generics Dashboard
B
Biosimilar BLAs	Biosimilars Dashboard
Biosimilar Development Programs Enrolled in the BPD Program	Biosimilars Dashboard
Breakthrough Therapy Designations	Drugs and Biologics Dashboard
C
Commercial INDs (Drugs)	Drugs and Biologics Dashboard
Commercial INDs (Biosimilars)	Biosimilars Dashboard
Conference Presentations	Policy and Science Development Dashboard
D
DSCs	Patient Safety Tools Dashboard
Drug Shortages	Drug Shortages Dashboard
E
Editorials	Policy and Science Development Dashboard
Efficacy Supplement	Drugs and Biologics Dashboard
F
FAERS Reports by Seriousness	Patient Safety Tools Dashboard
Fast Track Designations	Drugs and Biologics Dashboard
First Cycle Performance (GDUFA)	Generics Dashboard
First Cycle Performance Adjusted for Imminent Approval or Tentative Approval (GDUFA)	Generics Dashboard
First Generics	Generics Dashboard
G
Guidance Documents	Policy and Science Development Dashboard
J
Journal Articles	Policy and Science Development Dashboard
M
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)	Biosimilars Dashboard
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)	Drugs and Biologics Dashboard
N
NDAs	Drugs and Biologics Dashboard
Newly Approved REMS	Patient Safety Tools Dashboard
Non-Biosimilar BLAs	Drugs and Biologics Dashboard
Novel Drug Approvals	Drugs and Biologics Dashboard
O
Original Supplements for Category E and F	Biosimilars
P
PAS Applications	Generics Dashboard
Post-CRs (Meetings and Letters)	Generics Dashboard
Priority Review Determination	Drugs and Biologics Dashboard
Published Letters	Policy and Science Development Dashboard
R
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)	Drugs and Biologics Dashboard
Recall Events and Unique Products Recalled (including Class 1 Recalls, Class 2 Recalls, and Class 3 Recalls)	Compliance Dashboard
Regulatory and Other Actions for Pharmacy Compounders and Outsourcing Facilities	Compliance Dashboard
Regulatory Publications	Policy and Science Development Dashboard
REMS Assessments Submitted	Patient Safety Tools Dashboard
REMS Modifications Approved	Patient Safety Tools Dashboard
REMS Released	Patient Safety Tools Dashboard
Review and Scientific Articles	Policy and Science Development Dashboard
S
SrLCs	Patient Safety Tools Dashboard
Shared System REMS	Patient Safety Tools Dashboard
Standard Review Determination	Drugs and Biologics Dashboard
Supplements with Clinical Data	Biosimilars Dashboard
T
Total Publications	Policy and Science Development Dashboard