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 ...
Late last month, the FDA finalized a new guidance document, explaining the agency's current thinking on the circumstances that may arise in connection with an establishment inspection that it would consider to impose an inappropriate limitation on its inspection authority. The Food and Drug Administration Safety and Innovation Act (FDASIA) deems a drug or medical device adulterated if it has been manufactured processed, packed, or held in any factory, warehouse, or establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.
The ...
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