Introduction to EPARs and FDA Approval Packages: Finding and Analyzing Unpublished Information about Pivotal Studies 23 June 2008 Session Chair: Amy N. - ppt download
A look at three recent FDA approvals supported by RWE | Aetion
Summary of FDA Expedited Development and Review Programs. | Download Scientific Diagram
Fillable Online fda Product Approval Information Summary Basis of Approval OCTAGAM 5% - fda Fax Email Print - pdfFiller
How FDA Approves Drugs and Regulates Their Safety and Effectiveness - EveryCRSReport.com
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices - ScienceDirect
Frontiers | A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations
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
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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
Amylyx's ALS drug finally scores FDA approval, but that's just the tip of the iceberg for ALS research, founders say | Fierce Pharma
2020 FDA drug approvals
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies | NEJM
Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs - ScienceDirect
FDA Drug Approval Process - Drugs.com
Summary of FDA's Expedited Programs | Download Scientific Diagram
Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis | PLOS Medicine
FDA's Expedited Review Process: The Need for Speed
How to use FDA drug approval documents for evidence syntheses
How to access and process FDA drug approval packages for use in research | The BMJ
New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels | SpringerLink
U.S. FDA Approved Drugs from 2015–June 2020: A Perspective | Journal of Medicinal Chemistry
How FDA Approves Drugs and Regulates Their Safety and Effectiveness
A Survey of the Structures of US FDA Approved Combination Drugs | Journal of Medicinal Chemistry
