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trial, Incyte gains new approval for Jakafi, Sunovion files for new use of Aptiom and AstraZeneca resubmits its once withdrawn lung cancer drug Iressa.
FDA’s Orange Book Dispute Resolution Process May Grow Teeth With FTC Patent Listing Challenges
People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.
Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy
Total ban on background music is unnecessary, agency says in denying KEI’s petition. FDA points to new ‘major statement’ rule and its previous letters objecting to a sponsor’s use of music in ads and says it will continue case by case analysis of ‘all of the elements’ in an ad.