The US Food and Drug Administration’s extensions concerning a Perrigo Company PLC subsidiary’s OTC daily oral contraceptive application didn’t stop with needing additional time to review additional information it requested.
For First US OTC Birth Control Application, FDA Extends Time For Advisory Panel Discussion
After postponing planned November advisory committees’ meeting to have time to review more information it requested from sponsor HRA Pharma, FDA sets meeting for 9-10 May. Expanding meeting from one day to a day and a half should allow considering all views and questions about contraceptives.
