9 votes
Accepted

Does a KN95 that says 'non medical' helps to protect against COVID-19?

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 ...
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  • 680
5 votes
Accepted

Why are Drugs.com side-effect incidence rates so different from manufacturer/FDA reports?

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 ...
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  • 2,328
3 votes

What information is a US healthcare provider required to provide access to under the 21st Century Cures Act?

The regulations define two phases of expanding definitions of what information must not be blocked. Before October 6, 2022 The first phase is described in the Office of the National Coordinator for ...
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  • 2,328
3 votes

Does a KN95 that says 'non medical' helps to protect against COVID-19?

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 ...
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  • 131
3 votes

What is the authoritative US document that delineates concrete standards for vaccine approval?

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-...
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  • 12k
3 votes

Vaccine efficacy to get FDA approval

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 ...
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  • 12k
2 votes
Accepted

Relationship between FDA Agencies and the Advisory Committee

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 ...
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  • 5,872
2 votes
Accepted

The process of drug approval; The flow from R&D, planning a clinical trial to drug approval, or other additional process

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'...
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1 vote
Accepted

What is missing for the Pfizer-BioNTech vaccine to get "regular" FDA approval?

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 ...
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  • 498
1 vote

Does a KN95 that says 'non medical' helps to protect against COVID-19?

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 ...
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  • 817
1 vote
Accepted

Clinical implications of observed faster mutation rate of SARS-CoV-2 in group quarantine?

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 ...
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  • 13.2k
1 vote
Accepted

What happens when a candidate drug becomes an ATMP? What's the list of ATMPs?

■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 ...
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1 vote

Are there websites with clinical trial reports freely available for download?

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