9

In the US, in order for a mask to be labeled "medical", that mask must be approved by the FDA as a medical device. With so many new people manufacturing masks coupled with the public demand for masks, it is likely not profitable to delay to seek FDA approval. The FDA also is unlikely to approve a new manufacturer's mask without ASTM testing. Thus, ...


5

The numbers are different because the package insert rates are based on two clinical trials while the information on Drugs.com is determined by Cerner Multum, a commercial drug database. Adverse events frequencies reported in the drug prescribing information is typically determined by initial clinical trial data. The table included in your question indicates ...


3

Typically for an N95 mask to be considered "medical grade" it must be compatible with a sterile environment, such as by filtering both inhaled and exhaled air. Surgical masks provide some filtration of exhaled air, which is why they're useful in surgury (e.g. keep saliva off an operating region). I have an N95 mask advertised for environments with ...


3

There is no "authoritative document" like you ask for. The FDA doesn't set concrete standards for efficacy and safety; rather, they review applications for vaccines and other drugs on a case-by-case basis according to safety, efficacy, other available treatments, and severity of the condition. The FDA has issued guidance to industry about how they ...


3

https://www.fda.gov/drugs/development-approval-process-drugs provides some general information on how the FDA makes their decisions. There is no general "efficacy" threshold that must be met for approval. Summarizing the bullets on that site, approval depends on: Analysis of the target condition and available treatments If there are already ...


2

In the final stage of FDA's approval process, what is the 'agency'? What is the role of them? The agency is the Food and Drug Administration (FDA). They are an agency within the Department of Health and Human Services. As the article and quote in your question says, Although the agency isn't required to follow an advisory committee's recommendation, it ...


2

I'm afraid it would be frowned you all if I answered it by myself and took my response as a solution, but... As I mentioned in the comments section above, I found a very summarized resource on the FDA's web site. (1)FDA According to the FDA, Drug Review Steps Simplified is as follows.(This is a regular approve route. Not a shortcut-way.) BoxF1: Preclinical ...


1

Well, it turns out I was wrong: The Pfizer-BioNTech vaccine's Phase 3 trials have not been completed: US Government listing of the trials. They will not be over before 2023... The FDA approval requirements/process is summarized as follows: An Investigational New Drug application Pre-licensure vaccine clinical trials A Biologics License Application (BLA) ...


1

The mask protects people from the person wearing the mask. In surgery, my colleagues and I wear a mask to protect the patient's open wound from me. Do not make the mistake of thinking that you, as the mask wearer, are conferring a degree of protection that provides safety.


1

It has been previously observed that the SARS-CoV-2 virus was relatively stable at 1 mutation a month. However, recent studies, and the one you refer to suggest that this is incorrect. Based on current data, it seems as though SARS-CoV-2 mutates much more slowly than the seasonal flu. Specifically, SARS-CoV-2 seems to have a mutation rate of less than 25 ...


1

■What is the ATMPs I didn't clearly read from the EMA's description of the ATMP, whether the ATMP is as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval". Perhaps the noun "ATMP" has three different meanings; I was confused because of the mix of these in the EMA's site. Box1. Three ...


1

You could try ClinicalTrials.gov, where you can search a massive database of clinical trials in every stage of completion.


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