Priority review
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- FDA Advisory Committee Recommends Accelerated Approval of Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline
- Orphan Drugs
- The Global Need for Effective Antibiotics—Moving Towards
- Defining the Strategic Vision for the EMA 'Article 58' Process
- Pandemic, Politics, Public Health , and the FDA
- Mdl-Press-Release-171217.Pdf
- Accelerating Clinical Drug Development for Children with Tuberculosis
- Fda 2019 Year in Review Special Special Report Report
- Technology Convergence Compliance
- COVID-19 Vaccine Frequently Asked Questions
- The Hidden Lesson of the Vioxx Fiasco: Reviving a Hollow FDA by Rena Steinzor and Margaret Clune
- FD&C Act Chapter V Drugs and Devices > SEC. 524
- Insights Into Rare Disease Drug Approval: Trends and Recent Developments
- The Priority Review Voucher Program at the FDA: from Neglected Tropical Diseases to the 21St Century Cures Act
- The Prescription Drug User Fee Act: History Through the 2007 PDUFA IV Reauthorization Name Redacted Specialist in Drug Safety and Effectiveness
- FDA Incentives
- Federal Register/Vol. 80, No. 161/Thursday, August 20, 2015
- Page 306 TITLE 21—FOOD and DRUGS § 360N–1