Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

I was wondering what the checklist for an EUA looks like so I found the below. JJ said in his filing he sent the FDA the GMP data last week.

2017 Guidance § III.D.2.a recommends that the following information be included in any request for an EUA:

Description of product and its intended use

Description of the product’s FDA approval status

The need for the product, including whether there are adequate, approved, and available alternatives

Safety and efficacy information:

Required safety information will vary by product and emergency.
It can include, for example, controlled clinical trials, bench testing, and/or clinical experience if the circumstances warrant.

Early discussions with FDA about the required safety and efficacy information are critical.

A discussion of risks and benefits:

A discussion of risks and benefits should include: (a) measures taken to mitigate risk or optimize benefit;

(b) limitations, uncertainty, and data gaps;

(c) contraindications; and

(d) actual and potential threats posed by CBRN agents that may be relevant.

Information on chemistry, manufacturing and controls, and the sites of manufacture, including the current good manufacturing practices (CGMP) status of those sites

Information on the quantity of product on-hand and surge manufacturing capabilities

Information comparable to an FDA-approved package insert or instructions for use;

drafts of fact sheets for healthcare professionals and recipients of the product;

and a discussion of the feasibility of providing this information in an emergency (a sample of instructions for use for an EUA diagnostic panel for the coronavirus is available on FDA’s website)

Information to support an extension of a label’s expiration date, if sought

Any right of reference (a right of reference means “the authority to rely upon, and otherwise use, data submitted from reports of an investigation or data previously submitted to FDA in support of an application, including the ability to make available the underlying raw data for FDA audit”)

~Zorro, Y@h00 RLFTF finance conversations

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities