Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies | NEJM
How to use FDA drug approval documents for evidence syntheses
A Survey of the Structures of US FDA Approved Combination Drugs | Journal of Medicinal Chemistry
New Drug Therapy Approvals 2020 | FDA
Amylyx's ALS drug finally scores FDA approval, but that's just the tip of the iceberg for ALS research, founders say | Fierce Pharma
Frontiers | A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations
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 ...
Can we learn lessons from the FDA's approval of aducanumab? | Nature Reviews Neurology
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices - ScienceDirect
Summary of NDA Approvals & Receipts, 1938 to the present | FDA
Rush to judgement?
How to access and process FDA drug approval packages for use in research | The BMJ
Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018 | PLOS ONE
Summary of FDA Expedited Development and Review Programs. | Download Scientific Diagram
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
2021 FDA approvals
Introduction to EPARs and FDA Approval Packages: Finding and Analyzing Unpublished Information about Pivotal Studies 23 June 2008 Session Chair: Amy N. - ppt download
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
Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon - Cytotherapy
New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels | SpringerLink
Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs - ScienceDirect
Summary of FDA's Expedited Programs | Download Scientific Diagram
