PANEL MEETING TO CENTER ON POSTMARKETING COMMITMENTS
The FDA will call on its Oncologic Drugs Advisory Committee next month to provide recommendations on how drugmakers can better meet postmarketing commitments for drugs cleared under the accelerated approval process.
The advisory panel will meet Nov. 8 to "identify difficulties associated with completion of Phase IV commitments" and "provide advice to sponsors to assist in the planning and execution of postmarketing commitments of newly approved drugs," the FDA said. The meeting will take place in Gaithersburg, Md.
In addition to discussing strategies for postmarketing commitments, the committee will review the status of several Phase IV studies, including commitments for Pfizer's Celebrex, Johnson & Johnson's Doxil, Wyeth's Mylotarg and MedImmune's Ethyol.
For more information about the meeting, go to http://www.fda.gov/oc/advisory/accalendar/2005/cder12542d110805.html (http://www.fda.gov/oc/advisory/accalendar/2005/cder12542d110805.html).