Fast track product designation under the food and drug administration modernization ACT: The industry experience

摘要: With the passage of Food and Drug Administration Modernization Act (FDAMA), existing programs for expedited development approval treatments serious or life-threatening diseases were codified consolidated under administrative rubric fast track product designation. The four basic available with designation have been categorized by FDA as consisting meetings, written correspondence, review programs, dispute resolution. Despite some early skepticism industry, even FDA, that benefits not readily apparent since individual are generally without designation, there indications will be improvement Congress intended. Unlike which affect only part drug timeline, has potential to facilitate entire process. Industry requests dwarfed pre-FDAMA industry participation. Yet, best predictor future success failure is how well it working now. In order evaluate this, authors surveyed biotechnology pharmaceutical sponsors 32 designated products identified from public information sources present their findings in this paper.