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  1. Transparency

FDA-TRACK: CDER Index

FDA-TRACK: CDER 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

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 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, 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

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

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 Compounding 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

SLCs

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

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