Not at all, sorry, just grabbed the first link.. E
Post# of 154090
(Total Views: 470)
Posted On: 03/25/2021 2:09:00 AM
Re: Riztheinvestor #84174
Not at all, sorry, just grabbed the first link.. EUA as an emergency measure is extremely broad and classifies any "medical countermeasure" as valid..
It appears that Nader should have been using this terminology to describe the FDA and CytoDyn's discussion, would have saved a lot of confusion. It also appears that he was more focused on EUA and didn't give much significance of the terminology / process of pre-EUA. Just conjecture however. Also:
https://www.fda.gov/regulatory-information/se...uthorities
Quote:
C. PRE-EUA ACTIVITIES AND SUBMISSIONS
Early engagement between an industry or government sponsor and FDA about potential EUA products will facilitate more complete EUA requests and enhance FDA’s ability to review and ultimately grant the EUA as appropriate.
FDA also recognizes that circumstances can change rapidly, and planning for a potential emergency may unexpectedly transition to a response effort. Therefore, FDA strongly encourages the sponsor of a product that might be considered for an EUA, particularly one at an advanced stage of development, to contact the appropriate FDA Center before submitting a formal request for an EUA. For purposes of this guidance, these submissions and related interactions are referred to as “pre-EUA” activities.
It appears that Nader should have been using this terminology to describe the FDA and CytoDyn's discussion, would have saved a lot of confusion. It also appears that he was more focused on EUA and didn't give much significance of the terminology / process of pre-EUA. Just conjecture however. Also:
Quote:
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).3 The provisions in PAHPRA, described in section II of this guidance, include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats such as pandemic influenza. PAHPRA clarifies and enhances FDA’s authority to support emergency preparedness and response and foster the development and availability of medical products for use in these emergencies. These medical products, also referred to as “medical countermeasures” or “MCMs,” include drugs (e.g., antivirals and antidotes), biological products (e.g., vaccines, blood products, and biological therapeutics) , and devices (e.g., in vitro diagnostics and personal protective equipment).
https://www.fda.gov/regulatory-information/se...uthorities
(3)
(0)