About FDA

FDA-TRACK CDER Dashboard

Sign up to receive FDA-TRACK updates

Contents:

Note: Information is as of December 31, 2017. The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

CDER STRATEGIC AREA 1: Regulatory Review and Drug Safety

I. New Drug Application (NDA) and Biologics License Applications (BLA) Reviews

  1. Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted and approved

II. New Molecular Entity (NME) and new BLA Reviews

  1. Number of New Molecular Entity (NME) NDAs and new BLAs submitted and approved

III. NDA and BLA Efficacy Supplements

  1. Number of NDA and BLA efficacy supplements submitted

IV. New Drug Application (NDA) related submissions received in electronic Common Technical Document (eCTD) format

  1. Percentage of NDA related submissions in eCTD format and Total number of NDA related submissions

V. Fast Track designations granted, Accelerated Approval, Priority Reviews, and First Generics

  1. Number of Fast Track designations granted, Accelerated Approval, Orphan Drugs for Rare Diseases, and First Generics

VI. Presidential Emergency Plan for AIDS Relief (PEPFAR)

  1. Cumulative Number of Presidential Emergency Plan for AIDS Relief (PEPFAR) drug approvals since 2004

VII. Pediatric studies

  1. Number of pediatric studies completed (under both PREA and BPCA)and deferred (under PREA)

VIII. BsUFA measures

  1. Number of biosimilar investigational new drug applications (INDs) received in the month
  2. Number of initial advisory meeting requests received and meetings held in the month
  3. Number of biosimilar biological product development (BPD) Type 1-4 meeting requests received and meetings held in the month
  4. Cumulative number of biosimilar development programs in the BPD Program in the month
  5. Number of 351(k) BLAs approved in the month
  6. Number of 351(k) BLAs approved within the first cycle in the month

IX. Drug Promotion Measures: Responds to requests for comments on launch campaigns to ensure fair and balanced promotion

  1. Number of core initial promotional campaign material reviews completed in the month and percentage completed within timeframe

X. Post Market Requirements (PMR) and Commitments (PMC)

  1. Number of Postmarketing Requirements (PMRs) and Commitments(PMCs) established and fullfilled/released

XI. 18 month, Ten Thousand Patients Reviews

  1. Number of 18 month, ten thousand patient reviews initiated

XII. Serious Reported Adverse Events (AE) for drug/biologic products in CDER (15-day manufacture reports)

  1. Number of Adverse Events (AE) reported for drugs/biological products

XIII. Risk Evaluation Migitigation Strategy (REMS) reviews, assessments, and approvals

  1. Number of Risk Evaluation Mitigation Strategy (REMS) reviews, assessments, and approvals

XIV. Pediatric safety reviews

  1. Number of pediatric safety reviews completed (BPCA, PREA, and Pediatric Rule)

Go back to the Top


CDER STRATEGIC AREA 2: Drug Quality and Compliance

I. Enforcement Measures: Complains regarding professional and consumer materials

  1. Number and Percentage of complaints preliminarily reviewed and acknowledged within 30 days of receipt

II. Drug Quality Defects related to processing recall actions

  1. Number of recalls classified and products impacted by recall

III. Inspections and Enforcement of Compounders

  1. Number of compounding recall events 
  2. Number of warning letters issued to compounders and 503B outsourcing facilities
  3. Number of state referral letters issued concerning compounders
  4. Number of injuctions/consent decrees against compounders and 503B outsourcing facilities
  5. Total number of registered outsourcing facilities

IV. Key Project

  1. Pilot Project Program under the Drug Supply Chain Security Act

Go back to the Top


CDER STRATEGIC AREA 3: Transparency & Public Outreach

I. External Presentations

  1. Number of external presentations to Societies, Consortia, Industrial and Government organizations

II. Number of Drug Safety Communications (CDER-wide)

  1. Number of DSC (Drug Safety Communications)

III. Development of Medical Countermeasures Measures: Number of external interactions related to the development of medical countermeasures

  1. Number of presentations, interactions with sponsors, and interagency working group meetings for drug development

IV. Key Project

  1. Rare Diseases Program

Go back to the Top


CDER STRATEGIC AREA 4: Regulatory Science Research

I.Scientific and Review Publications

  1. Number of Scientific and Review Publications published

II. Issued Guidances

  1. Number of guidances issued

Go back to the Top

Subscribe

Sign up to receive FDA-TRACK updates

Page Last Updated: 05/23/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English