To help speed up development and review of generic drugs, the FDA has released 2 new documents aimed at streamlining and improving aspects of the submission and reviewing generic drug applications.
According to the statement, it currently takes the agency 4 review cycles on average for a new drug to reach approval, sometimes because the application is missing information needed to demonstrate that it meets approval standards. The new guidance will provide developers with key information about what is needed to avoid delays in the review process.
“Through today’s guidance, as well as others from the agency, we can achieve one of the FDA’s key goals in 2018–to reduce the number of review cycles–by helping applicants avoid these common deficiencies that lead to review delays and application cycling,” Dr. Gottlieb said in the statement.
Written by Jennifer Barrett
