If you would like to make an oral presentation, please send the following information to: Tara Turner, Pharm.D., Center for Drug Evaluation and Research
(HFD-21), 5600 Fishers Lane, Lane (for express delivery: 5630 Fishers Lane, rm.
Public Health Service, most recently served as a supervisory medical officer in the FDA's Center for Drug Evaluation and Research
. "Kathleen brings a breadth of professional experience, as well as a strong science background and passion for women's health, to her new position," said FDA Acting Commissioner Andrew von Eschenbach, M.D.
The primary regulatory responsibilities for and oversight of specific combination products will remain in either the Center for Drug Evaluation and Research
, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health, depending on prior assignment.
"An e-mail list has been established by the Division of Antiviral Drug Products (Center for Drug Evaluation and Research
) and the Office of Special Health Issues (Office of the Commissioner) of the Food and Drug Administration (FDA) to provide updates on safety and regulatory issues related to HIV/AIDS products.
Temple, director of medical policy at the FDA's Center for Drug Evaluation and Research
in Rockville, Md.
"Adobe Acrobat and PDF support online access to NDA submissions that simplifies distributing, locating, and archiving this huge volume of data," says Greg Brolund, associate director for technology and policy for the Center for Drug Evaluation and Research
at the FDA.
In collaboration with Frank Sistare, acting director of the Office of Testing and Research at the Food and Drug Administration Center for Drug Evaluation and Research
, the team obtained preliminary results from a rat model showing that cardiotoxicity was detected 90% of the time before clinical symptoms occurred.
The antifungal drug Cancidas (Merck & Co.) is in short supply, according to the FDA's Center for Drug Evaluation and Research
Go the FDA Docket page at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm click on the year 2000, scroll down to the Center for Drug Evaluation and Research
(CDER) meetings, and click on the name of the committee, the Antiviral Drugs Advisory Committee.
Peck, director of FDA's Center for Drug Evaluation and Research
"These studies are being widely done, and they may have tremendous progress," said Janet Woodcock, director of the FDA Center for Drug Evaluation and Research
, at the agency's 9 April 2003 Science Board Advisory Committee meeting.
"Contact Person: Nancy Chamberlin, or Beverly O'Neil, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, Rm.