Food and Drug Administration decision process to deny initial application for overthecounter marketing of the emergency contraceptive drug Plan B was unusual : report to congressional requesters.

Food and Drug Administration decision process to deny initial application for overthecounter marketing of the emergency contraceptive drug Plan B was unusual : report to congressional requesters.

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Appendix III: Timeline of Major Plan B Events Related to the Initial OTC Switch Application Date Event May 3, 2004 May 5, 2004 May 6, ... consent of the sponsor, the agency cannot publicly release data or information contained in an application before an approval letter is ... strategy in the amendment to the sNDA because of the absence of the draft product labeling describing how Barr Pharmaceuticals, anbsp;...


Title:Food and Drug Administration decision process to deny initial application for overthecounter marketing of the emergency contraceptive drug Plan B was unusual : report to congressional requesters.
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Publisher:DIANE Publishing -
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