Summary of NDA Approvals & Receipts, 1938 to the present | FDA
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Working with the FDA
New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels | SpringerLink
Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis | PLOS Medicine
The fragility of phase 3 trials supporting FDA-approved anticancer medicines: a retrospective analysis - The Lancet Oncology
New Drug Therapy Approvals 2020 | FDA
Fillable Online fda SUMMARY BASIS FOR APPROVAL PLA - Food and Drug ... - fda Fax Email Print - pdfFiller
How FDA Approves Drugs and Regulates Their Safety and Effectiveness - EveryCRSReport.com
Can we learn lessons from the FDA's approval of aducanumab? | Nature Reviews Neurology
Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018 | PLOS ONE
Summary of FDA's Expedited Programs | Download Scientific Diagram
A look at three recent FDA approvals supported by RWE | Aetion
U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab
Summary of FDA Expedited Development and Review Programs. | Download Scientific Diagram
2021 FDA approvals
Fillable Online fda Product Approval Information Summary Basis of Approval OCTAGAM 5% - fda Fax Email Print - pdfFiller
Steven Warach on Twitter: "Happy tPA Day! 25 years ago today FDA approved alteplase for ischemic stroke. The beginning of the stroke reperfusion revolution! https://t.co/BC4fZyt9VZ @NINDStrials @US_FDA @American_Heart @genentech @LoneStarStroke https ...
A Survey of the Structures of US FDA Approved Combination Drugs | Journal of Medicinal Chemistry
2020 FDA drug approvals
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices - ScienceDirect
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
U.S. FDA Approved Drugs from 2015–June 2020: A Perspective | Journal of Medicinal Chemistry
How to access and process FDA drug approval packages for use in research | The BMJ
FDA efficiency for approval process of COVID-19 therapeutics | Infectious Agents and Cancer | Full Text
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices - ScienceDirect
