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FDA-TRACK FY 2012 Q3 Most Visited Dashboard Pages

1. FDA-TRACK Advisory Committees Dashboard
2. FDA-TRACK Advisory Committees Dashboard - Archive
3. FDA-TRACK CBER Cross Management Support Offices Dashboard
4. FDA-TRACK CFSAN Food and Cosmetic Safety Dashboard
5. FDA-TRACK CDER Office of Generic Drugs Dashboard
6. FDA-TRACK CDER Office of New Drugs Dashboard
7. FDA-TRACK CDER Office of New Drug Quality Assessment Dashboard
8. FDA-TRACK Office of Special Medical Programs Dashboard
9. FDA-TRACK OC Office of the Chief Scientist Dashboard
10. FDA-TRACK Freedom of Information Act (FOIA) Dashboard

 

FDA-TRACK FY 2012 Q3 Most Visited Quarterly Briefing Summary Pages

Note: Quarterly briefing summaries are typically posted within 30 business days after the briefing date. 

1. March 28, 2011: FDA-TRACK OC Program Offices Quarterly Briefing Summary
2. April 30, 2012: FDA-TRACK NCTR Quarterly Briefing Summary
3. August 28, 2011: FDA-TRACK CDER Quarterly Briefing Summary
4. September 26, 2011: FDA-TRACK OSMP Quarterly Briefing Summary
5. February 1, 2012: FDA-TRACK CBER Quarterly Briefing Summary
6. February 22, 2012: FDA-TRACK CDRH Quarterly Briefing Summary
7. April 23, 2012: FDA-TRACK CVM Quarterly Briefing Summary
8. March 26, 2012: FDA-TRACK Advisory Committees Quarterly Briefing Summary
9. February 27, 2012: FDA-TRACK CDER Quarterly Briefing Summary
10. March 28, 2012: FDA-TRACK ORA Quarterly Briefing Summary

FDA-TRACK FY 2012 Q3 Top Program Measures Clicked

1. CBER: Percentage of manufacturing supplements (CBE and CBE-30 day Supplements) with action due dates occurring during the month that were reviewed and acted upon within 6 months of receipt (PDUFA)
2. CBER: Percentage of completed CBER action packages posted on the web within 30 days of complete action package receipt in OCOD
3. CDER: Percentage of New Drug Applications (NDAs) containing Quality by Design (QbD) elements (New Molecular Entity (NME) and non-NME). Cumulative total reported each Fiscal Year.
4. OSMP: Total number of orphan drug designation decisions that resulted in orphan designation in the month
5. CDER: The number of written Drug Master File reviews completed by ONDQA during the month
6. CDER: Number of applications received, applications pending, and actions taken
7. CDER: Percentage of New Drug Applications (NDAs) for new molecular entities (NMEs) containing Quality by Design (QbD) elements. Cumulative total reported for the Fiscal Year.
8. CDER: Number of Commercial and Research INDs received in the month
9. CFSAN: Number of mandatory adverse event reports from the dietary supplement industry entered into CAERS in the month 
10. Advisory Committees: Percent of FDA advisory committee member positions vacant at the end of the month

 

FDA-TRACK FY 2012 Q3 Top Key Projects Clicked

1. CDER: Quality by Design (QbD) Road Map
2. ACA: Implement Section 4205 of the Patient Protection and Affordable Care Act
3. NCTR: Toxic/Carcinogenic Effects of Dietary Supplements and Food Container Materials
4. OSMP: Orphan Drug Designation Standard Operating Policy and Procedure (SOPP)
5. CDRH: Medical Device Epidemiology Network (MDEpiNET)
6. CDRH: Personalized Medicine
7. OIP: Train-the-trainer Good Clinical Practices (GCP)
8. OIP: Over-the-Counter (OTC) Good Manufacturing Practices (GMP) Pilot
9. OC: Standard Operating Procedures
10. ACA: Establish an abbreviated regulatory review pathway for biosimilar and interchangeable biological products

FDA-TRACK FY 2012 Q3 Top XML Downloads

Note: All Program Measures and Key Projects are downloadable in XML format.

1. CDER: Quality by Design (QbD) Road Map
2. CDRH: International Regulators Device Forum
3. CDER: The number of written Drug Master File reviews completed by ONDQA during the month
4. CDRH: Personalized Medicine
5. OSMP: Orphan Drug Designation Standard Operating Policy and Procedure (SOPP)
6. OSMP: Humanitarian Use Device (HUD) Guidance
7. OSMP: Total number of orphan drug designation decisions that resulted in orphan designation in the month
8. OC: Standard Operating Procedures
9. NCTR: Toxic/Carcinogenic Effects of Dietary Supplements and Food Container Materials
10. CBER: Percentage of manufacturing supplements (CBE and CBE-30 day Supplements) with action due dates occurring during the month that were reviewed and acted upon within 6 months of receipt (PDUFA)