- Home
- » Tags
- » Priority review
Top View
- 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
- Patents and Infectious Disease Products Jonathan J
- Regulatory Explainer: Everything You Need to Know About FDA\222S Priority Review Vouchers
- YEAR-END REPORT - 2020 Published 21-Dec-2020 HPTS Issue Brief 12-21-20.37
- Messner Thesis (Siingle-Sided A4
- FDA's Patient-Focused Drug Development Initiative
- Supporting the Approval of a Treatment for a Neglected Tropical Disease
- Creative Use of the Priority Review Voucher by Public and Not-For-Profit Actors Delivers the First New FDA-Approved Treatment for River Blindness in 20 Years
- 212862Orig1s000 OTHER REVIEW(S)
- SIRTURO (Bedaquiline) 100 Mg Tablets
- Testimony of Scott Gottlieb, M.D. Commissioner of Food
- THE S.A.M. NEWSLETTER Healthcare Market Review April 2005 Volume 4.3 and Outlook
- Overview and Considerations for COVID-19 Vaccines
- GAO-20-244, FDA DRUG APPROVAL: Application Review Times Largely Reflect Agency Goals
- FDA's Priority Review Voucher Programs
- FDA) Commissioners Who Called for Restructuring the FDA As an Independent Federal Agency
- Legal Issues in COVID-19 Vaccine Development and Deployment
- The Economics of Orphan Drugs: the Effectiveness of Priority Review
- Vioxx's History and the Need for Better Procedures and Better Testing
- New Market Incentive to Encourage Innovation for Global Health FDA Bill Creates Priority Review Voucher for Neglected Tropical Diseases
- S. Hrg. 109-99 NOMINATION of LESTER M. CRAWFORD
- Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2009 Hearings Committee On
- Congress Vouches for Priority Review of Childhood Disease
- U.S. Fda Grants Priority Review for the Biologics License Application for Pfizer-Biontech Covid-19 Vaccine New York and Mainz
- Neglected Tropical Diseases: Background, Responses, and Issues for Congress
- The FDA Is Not the Problem Why Undermining the Drug Approval Process Is Not the Answer to High Drug Prices
- U.S. FDA Grants Priority Review to Janssen's New Drug Application For
- What Commissioner Gottlieb's FDA Is Doing to Lower Prescription Drug
- Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization As PDUFA VI
- FY 2019 PDUFA Performance Report Commissioner’S Report
- Argenta Collaborates on FDA Approval of a Novel Treatment for River Blindness
- Designing Antifilarial Drug Trials Using Clinical Trial Simulators
- Orphan Drug Development Guidebook Building Block U210
- Page 275 TITLE 21—FOOD and DRUGS § 360N §360N. Priority
- Expedited Programs for Serious Conditions – Drugs and Biologics
- PDUFA Lays the Foundation: Launching Into the Era of User Fee Acts
- Anthelmintic Drug Discovery: Target Identification, Screening Methods and the Role of Open Science
- A Year in Review