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Having the Office of New Drugs (OND) and Office of Drug Safety (ODS) within the FDA’s Center for Drug Evaluation and Research (CDER) ensures efficient decisionmaking, expeditious resolution of disputes and the rapid dissemination of critical drug safety information, according to the head of CDER.
The Center for Drug Evaluation and Research's (CDER) new Drug Safety Oversight Board (DSB) will consist of voting members from nine different FDA offices and two agencies outside the FDA, according to a newly released FDA Manual of Policies and Procedures (MAPP).
The FDA’s nationwide search for a director to lead its new Office of Oncology Drug Products (OODP) ended close to home, as the agency selected current FDA official Richard Padzur to run the office.
The FDA has delayed its timetable for restructuring the Office of New Drugs (OND), but some activities already are moving forward at the OND, including in the unit that reviews cancer products.
The number of adverse event reports submitted to the FDA’s Center for Drug Evaluation and Research (CDER) increased nearly 14 percent in 2004, according to a preliminary estimate from the agency.
The FDA has pushed back its timetable for a major restructuring of the Office of New Drugs (OND), but some activities already are moving forward at the OND, including in the office that reviews cancer products.
Sponsors intending to submit a new drug application (NDA) or biologic license application (BLA) related to agents designed to help rid the body of radiological contamination from a terrorist attack or accident should consult with FDA officials prior to making their submissions — especially if they intend to seek approval under the Animal Efficacy Rule.
More than 20 members of Congress have sent a letter to FDA acting Commissioner Lester Crawford seeking an explanation for an alleged smear campaign launched by agency officials against David Graham, the agency scientist who blew the whistle on safety concerns associated with the drug Vioxx and other Cox-2 inhibitors.
A Democratic senator says a new FDA commissioner is needed to correct alleged problems at the agency, but observers of the agency and the pharmaceutical industry contend the current leadership is not at fault.