Ebola Vaccines: FDA Weighs Alternative Study Designs, Approval Pathways
This article was originally published in The Pink Sheet Daily
Executive Summary
As incidence of Ebola declines, advisory committee will consider alternatives to randomized controlled trials – an approach FDA had previously argued was inappropriate.
You may also be interested in...
Regulatory Briefs: Ebola Trials Protocol, AstraZeneca Resubmits Iressa
FDA officials explain why randomized clinical trials of Ebola products are necessary and the Senate passes Ebola priority review voucher bill. Lilly/AstraZeneca start Alzeimer’s trial, Incyte gains new approval for Jakafi, Sunovion files for new use of Aptiom and AstraZeneca resubmits its once withdrawn lung cancer drug Iressa.
Pharmacies Likely To Cease Prescribing COVID-19 Therapeutics With End Of Public Health Emergency
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.
FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.