On Track: The FDA-TRACK Monthly Newsletter

Learn More: FDA Social Media Enhancement

The Office of External Affairs (OEA) began an initiative in FY14 with the Center for Drug Evaluation and Research (CDER) to improve consumer engagement by enhancing its social media responses, specifically to drug related inquiries more quickly and proactively. This initiative began as a 90 day pilot program, but due to its success, the program has become fully operational. The pilot program involved several CDER employees working together with OEA employees to respond to drug related inquiries posted on FDA’s Facebook page. As a result of this collaboration, FDA was able to respond to inquiries within two business days. CDER found this method to be an extremely effective way to communicate with consumers and permanently assigned one CDER employee to be responsible for responding to these inquiries going forward. The employee now has direct access to post responses and manage the drug related content on behalf of CDER on FDA’s Facebook page. Further, it was recognized that some of the same topics were frequently asked, and therefore, CDER developed a frequently asked questions and answers file to respond to consumers even faster. Now, CDER is able to respond to drug related inquiries within one business day. OEA has now begun working with the Office of Foods and Veterinary Medicine, largely with the Center for Food Safety and Applied Nutrition, on a pilot program and anticipates working with other Centers to develop similar programs and increase FDA’s overall response rate to social media inquiries. For more information on OEA’s social media measures, please visit the OEA Dashboard within the OC Administrative Offices Dashboard.

What's New in June 2015

New performance data are available for the dashboards below.

Center for Devices and Radiological Health (CDRH)

CDRH Dashboard: As of FY15 Q2, CDRH has reviewed 75% of device types/product codessubject to a premarket approval (PMA) to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, reaching the FY15 Q3 target (75%) ahead of schedule.

Center for Drug Evaluation and Research (CDER)

CDER Dashboard: At the May briefing, the Office of Generic Drugs highlighted that CDER hasapproved 27 First Generics (the first time a particular drug is approved in generic form) in FY15 year-to-date, including 11 in FY15 Q2. Follow the achievements of First Generics through CDER’s Regulatory Review and Drug Safety strategic area on the dashboard.

Center for Food Safety and Applied Nutrition (CFSAN)

CFSAN Dashboard: In the first half of FY15, the Office of Compliance took environmental samples from 71 firms, 22 of which had positive samples. Check out more safety and compliance measures in the Office of Compliance section of the dashboard.

Office of International Programs (OIP)

OIP Dashboard: Through FY15 Q2, 110 inspections of regulated foreign establishments were completed by in-country investigators and detailees.

Office of Regulatory Affairs (ORA)

ORA Dashboard: Through FY15 Q2, 198 external presentations were provided to societies, consortia, industry, and government organizations about the national and worldwide function of ORA.