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For First US OTC Birth Control Application, FDA Extends Time For Advisory Panel Discussion

 
• By Lauren Nardella

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.

• Source: Shutterstock

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.

The agency has stretched an advisory panel meeting it will conduct to discuss the application from one day to a day and a half.

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