On Track: The FDA-TRACK Monthly Newsletter

Learn More: First Generics Review Program

The generic drug review program, including the Office of Generic Drugs, is experiencing the benefits of the Generic Drug User Fee Amendments of 2012 (GDUFA) resources. We have hired and trained additional staff members, enhanced operational infrastructure, and improved communications within the Agency to facilitate reviews and inspections. Further, we have significantly enhanced communications with industry.

Our program improvements are beginning to pay off. We can transition from restructuring the program to focus on approving abbreviated new drug applications (ANDAs) to introduce new safe, effective, quality, substitutable generic drug products within the GDUFA time frames.

In addition, we have approved more than 50 first generic drugs so far this calendar year, as of September 1, 2015. First generics are an important subset of ANDAs in that they are often blocked from FDA approval by patents and exclusivities that Congress created to incentivize new drug development. “First generic” ANDAs are the first ANDAs that are no longer blocked by patents or exclusivities. Some first generic approvals include generic versions of Nexium, Copaxone, and Abilify.

First generics open the market to generic competition for the first time, dramatically improving access to affordable, quality drug products, often at a substantially lower cost. To learn more, take a look atCDER’s FDA-TRACK Dashboard and the ANDA (Generic) Drug Approvals page.

What’s New in September 2015

New performance data are available for the dashboards below.

Center for Biologics Evaluation and Research (CBER)

CBER Dashboard: CBER began reporting on three new measures in FY15 Q3: the number of breakthrough therapy designation requests received, the number of designation approvals, and the number of designations withdrawn after granting (WAG) and rescinded.

Center for Drug Evaluation and Research (CDER)

CDER Dashboard: As of FY15 Q3, CDER has 51 total registered 503B outsourcing facilities.CDER began tracking measures on the Inspection and Enforcement of Compounders in October 2014.

Center for Food Safety and Applied Nutrition (CFSAN)

CFSAN Dashboard: As of FY15 Q3, the Office of Nutrition, Labeling and Dietary Supplements (ONLDS) has completed 100% of its new dietary supplement (NDI) reviews within 75 days of filing. The median average to complete a review in FY15 is 69 days.

Center for Tobacco Products (CTP)

CTP Dashboard: Through three quarters of FY15, 117,227 retailer compliance check inspections were completed, already surpassing the annual FY15 target of 105,000 inspections.

Center for Veterinary Medicine (CVM)

CVM Dashboard: In FY15 Q3, the Office of Surveillance and Compliance (OSC) completed 90% of its warning letter reviews within 15 days.

Office of the Commissioner (OC)

Office of Operations (OO) Dashboard: The Office of Facilities, Engineering, and Mission Support Services (OFEMS) completed the Consolidation of the Biodefense Laboratory Complex (BLC) to the White Oak Campus. The BLC facilitates over 2,500 FDA workers and encompasses over 1,250,000 square feet of new office and laboratory space.

OC Administrative Offices Dashboard: In FY15 Q3, the Division of Docket Management (DDM) began reporting on a new measure to track the number of new Federal Register Dockets created during the month by DDM. There were 27 new Federal Register Dockets created in April, as well as 14 in May and 17 in June. In addition, DDM processed 100% ofFederal Docket Request Check Research requests on time.

Office of International Programs (OIP)

OIP Dashboard: Through FY15 Q3, 181 inspections of regulated foreign establishments were completed by in-country investigators and detailees.

Office of Regulatory Affairs (ORA)

ORA Dashboard: Through FY15 Q3, 362 external presentations were provided to societies, consortia, industry, and government organizations about the national and worldwide function of ORA, exceeding the FY14 total.