This
draft guidance intended to assist applicants preparing to submit to FDA abbreviated
new drug applications (ANDAs).
This
guidance highlights common, recurring deficiencies that may lead to a delay in
the approval of an ANDA. It also makes recommendations to applicants on how to avoid
these deficiencies with the goal of minimizing the number of review cycles necessary
for approval.
FDA
is also issuing a Good ANDA Assessment Practices Manual of Policies and
Procedures which establishes good ANDA assessment practices for the Office of
Generic Drugs and the Office of Pharmaceutical Quality to increase their operational
efficiency and effectiveness.
Posted by Dr. Tim Sandle
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