Moderna’s COVID-19 Vaccine To Get Real-Time Data Assessment By US FDA
Executive Summary
Commissioner Hahn says FDA will see data as it is compiled to speed review; enrollment criteria raises some eyebrows since Moderna plans to exclude patients with known history of SARS-CoV-2 infection from Phase III. The agency’s guidance on COVID-19 vaccine trials says that such exclusions are not necessary since screening is unlikely when a product would be delivered post-market.
You may also be interested in...
PDUFA VII Could Expand US Real-Time Review Beyond Oncology
A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.
US FDA's Presubmission Expedited Regulatory Programs Eyed For Streamlining
Agency staff, stakeholders see advantages to bundling requirements for fast-track and RMAT designations into a single, pre-breakthrough therapy pathway, and codifying processes and interactions that take place following award of breakthrough designation; proposal is aimed at reducing current programs' redundancies and maximizing benefit of frequent, early interactions with the FDA.
After Pandemic, US FDA Commissioner Wants To Continue ‘Rolling Review’ Offered To COVID-19 Products
Stephen Hahn also said the expedited approval process could be even more efficient.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: