Katrina’s Blog™

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on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.

Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)

April 14, 2020
| COVID

Chapter 11 – CDER Creates a Single Site for Its COVID-19 Response Activities

So much new information is being released daily by the FDA in response to the COVID-19 outbreak that it can be hard to keep track of the latest developments or current guidance. Some immediately in effect guidance have been updated a couple of times since their first issuance. To help drug innovators and manufacturers, CDER has created a single website for all COVID-19 activities related to drugs. This is separate from the main FDA Coronavirus Disease 2019 webpage, which presents a running feed of everything COVID-19 from the FDA arranged by date or by content using a simple filter tool. CDRH is a bit behind on their update strategy – they are posting everything to the CDRH New web page regardless of its content (though most currently is related to COVID-19 response). And if you are interested in biologics, check out the CBER New web page.

Reach out to me if you want to know more or discuss your medical product development challenges.

katrina@krogersconsulting.com

https://www.linkedin.com/company/katrina-rogers-consulting-llc
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Text Copyright © 2020 Katrina Rogers, Image courtesy of the CDC

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