RE: SNG001 - the primary version of interferon beta-1a.11 Oct 2020 15:56
On availability, it certainly (and sensibly) looks like a key part of the emergency use criteria:
What is needed for a formal EUA request?
The FDA recommends that Sponsors include a well-organized summary of as much of the following as possible when applying for an EUA:
A description of the product and intended use
A description of the product’s FDA approval status
Efficacy and safety information, including data from any clinical studies and nonclinical in vivo and in vitro data: The threat posed and the nature of the product determine how comprehensive the evidence for EUA issuance needs to be. However, the requirements are typically less stringent than those for product approvals. The FDA considers a number of factors, including whether the product has already been approved for another indication and, if unapproved, its stage of development.
An analysis of the risks and benefits, including any measures taken to mitigate risk or optimize benefit, any contraindications, and any gaps in data
Information on the chemistry, manufacturing, and controls of your product: The request must demonstrate final product availability and the manufacturing sites’ surge capabilities. Notably, certain current Good Manufacturing Practice requirements may be waived for EUAs to accommodate emergency response needs.
Information on any available and approved alternatives to your product
A fact sheet providing information on dosing, contraindications, warnings, and adverse events for distribution to health care workers and authorized dispensers of your product
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