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An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary.
One person said that a number of staffers at the FDA are up for retirement, and “ some may think now would be an opportune time to do so.” There are more than 18,000 employees at the FDA ...
The legal basis for the Schedule Policy/Career appointment is a section of the Civil Service Reform Act of 1978), which exempts from civil service protections federal employees "whose position has been determined to be of a confidential, policy-determining, policy-making or policy-advocating character". The provision had been little noticed and ...
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
Troy’s dismissal of Kennedy as a profound public health threat is the contrarian opinion thus far, with FDA employees and public health officials sounding the alarms on the future of health ...
Editor's note: A previous version of this article erroneously referred to Sarepta and Tekmira's drugs as vaccines, and mentioned that MAP Pharmaceuticals was developing an Ebola therapy. The Fool ...
A Title 42 appointment is an excepted service employment category in the United States federal civil service.It allows scientists and special consultants to be hired as part of the Public Health Service or Environmental Protection Agency under a streamlined process "without regard to the civil-service laws".
application form that contains the following: (1) The name and address of the applicant; the date of the application; the application number if previously issued (for example, if the application is a resubmission, an amendment, or a supplement); the name