How to Expedite Drug Approval | RegDesk | Professional software
The Need for Speed in Drug Development: A Sponsor's Guide to FDA Expedited Programs | Halloran Consulting Group
Fresh from the biotech pipeline: fewer approvals, but biologics gain share | Nature Biotechnology
Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions - EveryCRSReport.com
CMC-Related Technical and Regulatory Aspects for Development of Biotherapeutic Products
FDA's Expedited Review Process: The Need for Speed
Frontiers | A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations
Rolling Reviews During COVID-19: The European Union Experience in a Global Context - ScienceDirect
TRIbune Winter 2015 - The FDA's Expedited Review Process: The Need for Speed
Center for Drug Evaluation, Taiwan
Accelerate Your Review with Rolling NDA & BLA Submissions
FDA's Framework for Regulating Regenerative Medicine Will Improve Oversight | The Pew Charitable Trusts
A User Guide To FDA's
CytoDyn submits the first section of HIV BLA to FDA under rolling review | Seeking Alpha
Vertex/CRISPR to begin rolling review in US for gene-edited therapy; get FDA designations | Seeking Alpha
CDER 21st Century Review Desk Reference Guide
What to Expect During the NDA Review Process
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities | SpringerLink
Real-Time Oncology Review | FDA
A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU - da Costa Gonçalves - 2022 - Clinical and Translational Science - Wiley Online Library
Rolling Reviews During COVID-19: The European Union Experience in a Global Context - ScienceDirect
Assessing the FDA's real-time oncology review program
