Posts tagged REalStar Ebolavirus RT-PCR Kit 1.0.
Blogs
2 minute read
On November 10, 2014, FDA authorized emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0, an in vitro diagnostic device for the detection of Ebola viruses. This is the most recent in a series of measures taken by FDA in recent months to facilitate rapid access to drugs, biologics and medical devices with potential benefits in the prevention, diagnosis or treatment of infections with the Ebola virus.
Emergency Use Authorization
Pursuant to Section 564 of the Food Drug & Cosmetic Act (21 U.S. Code § 360bbb–3), The Secretary of the Department of Health and Human Services may ...
Blog Editors
Recent Updates
- Supreme Court of Ohio Decides on a Peer-Review Privilege Issue in Stull v. Summa
- Unpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA
- Importance of Negotiating the Letter of Intent for Health Care Leases
- Importance of Negotiating Default Provisions in Health Care Leases
- Podcast: Health Policy Update: Impact of the 2024 U.S. Elections – Diagnosing Health Care