A Survey of the Structures of US FDA Approved Combination Drugs | Journal of Medicinal Chemistry
FDA's Expedited Review Process: The Need for Speed
How to use FDA drug approval documents for evidence syntheses
How FDA Approves Drugs and Regulates Their Safety and Effectiveness - EveryCRSReport.com
Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon - Cytotherapy
Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018 | PLOS ONE
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices - ScienceDirect
FDA efficiency for approval process of COVID-19 therapeutics | Infectious Agents and Cancer | Full Text
U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies | NEJM
Summary of FDA Expedited Development and Review Programs. | Download Scientific Diagram
Working with the FDA
Summary of NDA Approvals & Receipts, 1938 to the present | FDA
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices - ScienceDirect
Fillable Online fda SUMMARY BASIS FOR APPROVAL PLA - Food and Drug ... - fda Fax Email Print - pdfFiller
How to access and process FDA drug approval packages for use in research | The BMJ
Can we learn lessons from the FDA's approval of aducanumab? | Nature Reviews Neurology
Fillable Online fda Product Approval Information Summary Basis of Approval OCTAGAM 5% - fda Fax Email Print - pdfFiller
FDA efficiency for approval process of COVID-19 therapeutics | Infectious Agents and Cancer | Full Text
Introduction to EPARs and FDA Approval Packages: Finding and Analyzing Unpublished Information about Pivotal Studies 23 June 2008 Session Chair: Amy N. - ppt download
Alexander Tin on Twitter: "As promised yesterday, @US_FDA has posted its "Summary Basis for Regulatory Action" document on @pfizer-@BioNTech_Group's COVID-19 vaccines full approval https://t.co/gytKOptwYf https://t.co/TZrlSrhm2C" / Twitter
A look at three recent FDA approvals supported by RWE | Aetion
