On Track: The FDA-TRACK Monthly Newsletter
Social Media Day was June 30th! Check out the Office of External Affairs (OEA) Social Media Enhancement Measures on the OC Administrative Offices Dashboard and the Office of Cosmetics and Colors (OCAC) Communication and Outreach Measures on the CFSAN Dashboard!
What’s New in June 2016
New performance data are available for the dashboards below.
Center for Biologics Evaluation and Research (CBER)
- CBER Dashboard: CBER’s Office of Compliance and Biologics Quality (OCBQ) product recall measures demonstrate their success under the Direct Recall Classification (DRC) program. CBER’s DRC program continues to perform at a consistent and high level with percentage of recalls classified within 45 days for both FY 2016 Q1 and Q2 at 97%.
Center for Drug Evaluation and Research (CDER)
- CDER Dashboard: CDER’s Office of Compliance began tracking a new key project in FY 2016 Q2, the Pilot Project Program under the Drug Supply Chain Security Act (DSCSA). The project design will focus on utilizing the product identifier for product tracing; improving the technical capabilities of the supply chain; and identifying the system attributes that are necessary to implement the requirements established under the DSCSA. This project promotes patient safety by enhancing the security of the pharmaceutical distribution supply chain.
Center for Food Safety and Applied Nutrition (CFSAN)
- CFSAN Dashboard: CFSAN’s OCAC is aiming to inform and engage stakeholders by effectively communicating cosmetic safety information based on the post-market surveillance of cosmetic products and ingredients and industry globalization. By expanding use of social media and other languages, OCAC hopes to maximize the reach of its safety and regulatory messaging. In FY 2016 Q2, OCAC sent out 100 tweets, a 9% increase from Q1. As of Q2 end, OCAC also translated 4 webpages which garnered 866 page views per month.
Center for Veterinary Medicine (CVM)
- CVM Dashboard: CVM receives thousands of adverse event (ADE) reports and monitors closely to identify safety signals of concern. In FY 2016 Q2, CVM received 5,622 ADE reports, of which 2.03% were Tier 1 reports that were given priority as they contained important safety information regarding product usage after approval.
Office of the Commissioner (OC)
- OC Administrative Offices Dashboard: The Office of External Affairs (OEA) measure for thenumber of visitors to the newsroom on fda.gov increased by 15% when comparing the FY 2016 Q2 average to the overall average. The increase in visits demonstrates OEA’s success from holding workshops and outreach events. This can also be attributed to the Patient Network Newsletter link to the Patient Network web pages and to FDA's news releases.
Office of International Programs (OIP)
- OIP Dashboard: Through the first two quarters in FY16, 112 on-site inspections of regulated foreign establishments were completed by in-country investigators and detailees.
Office of Regulatory Affairs (ORA)
- ORA Dashboard: ORA redesigned its dashboard to track measures that are aligned to FDA’s core mission goals and objectives including, (1) Enhance Oversight of FDA-Regulated Products, (2) Improve and Safeguard Access to FDA-Regulated Products to Benefit Health, and (3) Promote Better Informed Decisions about the Use of FDA-Regulated Products.