FDA official details common reasons for missing ANDA review dates
North Bethesda, MD -- The US Food and Drug Administration (FDA) “never gives up on applications” that miss their review goals under the Generic Drug User Fee Amendments (GDUFA) program, said Ted Sherwood, director of the Office of Regulatory Operations (ORO) in the Office of Generic Drugs (OGD).Sherwood also discussed some common reasons for missing review goal dates during the agency’s Generic Drugs Forum (GDF) on 9 April.
“We do not want to miss our goal dates. We understand how frustrated applicants can become, and we share that frustration when deadlines are missed. We apologize for this situation, as it's not where we want to be,” he said, adding that “there are many efforts underway to ensure that these goal dates are met.”
He mentioned that there are not many applications that miss their goal dates and said he understands how important it is for companies to meet these dates.
Sherwood stressed that FDA can only approve ANDAs when all criteria are met, and that only then “can we move the application forward. A missed goal date is when [industry] could not put everything together in time to close out the approvals.”
For instance, Sherwood indicated that the FDA may need to establish a new review goal date if a company submits an amendment to an existing application; he noted that submitting the amendment "will change the goal date."
Or in other situations, FDA may review an application and determine that an inspection is necessary and decide to extend the review goal date by four months.
The GDUFA III commitment letter states that “if an RPM [regulatory project manager] learns that FDA is likely to miss the goal date for an ANDA, the RPM will notify the applicant of the delay in taking an action, identify the general reason for the delay including the outstanding discipline(s), if any, and the estimated time for FDA’s action on the application.”
For many of the pending ANDAs that do not meet their review goals, he said “there’s a lot of communications going on across the agency every single day between the different project managers and each of the disciplines” on moving the application through the review queue.
ORO has a “command center” that tracks all the applications with missed review goal dates. He said that the office tracks 1,400 applications that are “in flight” at any given time.
FDA can also miss its review goals when complex regulatory issues are involved, Sherwood said, such as policy issues or issues with exclusivity that may hold up the review. Other delays can arise from data integrity problems in applications.
Sherwood said that “you would not believe the level of effort” that FDA invests in addressing data integrity issues. Resolving these issues often involves daily meetings with staff to determine which applications were impacted by data falsifications.
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