Thinking Post-COVID: How Will US FDA Transition Drug, Vaccine EUAs To Full Approvals?
Sponsors seek clarity about the transition process, which could last a year or longer.
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Supplemental Filings: Gene Therapy Harmonization Moving Ahead; US FDA’s COVID-19 EUA Authority Hanging Around
Peter Marks suggests the need for a ‘compromise’ on gene therapy. Elizabeth Sadove looks towards an extended tenure for COVID products under EUAs.
Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.
The Medicines Patent Pool has conducted a study on the impact of licensing and technology transfer on the timeline and costs of developing five biosimilars, including Merck’s Keytruda. While a licensing deal for pembrolizumab might not be a near-term possibility, the findings could help licensors, licensees and regulators increase access to medicines.