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drug approval process, FDA grants early approval of drugs found to provide meaningful benefit over existing therapies for serious or. File Format: PDFAdobe Acrobat - View as HTML If we cheer and support the approval of drugs or biologics when there is no evidence of substantial efficacy we will not be taken seriously. Drug Approval Application Process. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited Understanding research in the. Citing organizational and cultural problems within FDA that hinder its post-approval drug
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