The US Agency released two documents aimed at improving aspects of the submission and review of generic drug applications. The new guidances for ANDA applications are:
Usually generic approvals are delayed as many applications undergo multiple review cycles. This guidance points out frequent deficiencies of ANDA procedures and makes recommendations on how to avoid them in order to minimise the number of review cycles necessary for approval.
It comprises internal practices and procedures followed by CDER to help standardise the drug review process and other activities, both internal and external.
FDA believes that these documents will enable the reduction of review cycles by helping applicants avoid common
deficiencies that lead to review delays and application cycling, which was one of the FDA’s key goals in2018.
Asphalion has extensive experience in FDA Submissions. Contact us for US regulatory support at fda@asphalion.com
