Questions tagged [regulatory-agencies]
The regulatory-agencies tag has no usage guidance.
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What information is a US healthcare provider required to provide access to under the 21st Century Cures Act?
In the United States, in response to the 21st Century Cures Act, the Department of Health and Human Services has developed regulations that prohibit "information blocking".
This publication ...
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What are DRVs and RDIs in "daily values" (DVs) for nutrition labeling?
The U.S. Food and Drug Administration (FDA) set "Daily Values" (DVs) for labeling foods that are comprised of Daily Reference Values (DRVs) and the Reference Daily Intakes
(RDIs). From here:...
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Why are Drugs.com side-effect incidence rates so different from manufacturer/FDA reports?
Entries at Drugs.com have a section on "Side Effects... For Healthcare Professionals" which present percentages for incidence rates of side effects. However, I've found that the rates ...
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What is the authoritative US document that delineates concrete standards for vaccine approval?
What is the authoritative US document that delineates concrete standards for vaccine approval? Presumably said document would be from the FDA. By concrete, this should include all measurable ...
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Vaccine efficacy to get FDA approval
What is the required efficacy level for a COVID-19 vaccine to get FDA approval?
I heard the numbers 50% and 60% - but can not find any document which would explicitly say so.
My concern is that two ...
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What is missing for the Pfizer-BioNTech vaccine to get "regular" FDA approval?
Last year, the US FDA issued an "Emergency Use Authorization" for Pfizer-BioNTech vaccine for Covid-19.
I read the wikipedia page on what that means, and it seems as though this can be ...
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Can COVID-19 vaccines cause birth defects?
Have regulators historically allowed enough time for Phase 3 trials to show that a vaccine does not cause congenital defects? Are they making an exception for Covid vaccines?
Because the Pfizer/...
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How to find FDA's and EMA's review reports and related minutes
Lately, I've been thinking about how we can't make various decisions without going back to what data and the logic behind the drug's approval. I'd like to ask a question about how to search such ...
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Relationship between FDA Agencies and the Advisory Committee
This article has the following descriptions;
"Perhaps what is most surprising is that in mid-August, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 1 to recommend the drug for ...
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The process of drug approval; The flow from R＆D, planning a clinical trial to drug approval, or other additional process
I'd like to know the process of drug approval; the flow from R＆D, planning a clinical trial to drug approval, or other additional process.
As far as I am aware, some documents provide too much detail ...
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What is the definition and significance of administration of "Compassionate Use Drug"?
There seems to be some conflict about the use of "Compassionate Drug Authorizations".
Does the request and use of such a drug indicate that a patient is in extreme danger?
Barkground:
The ...
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Does a KN95 that says 'non medical' helps to protect against COVID-19?
I saw this type of face masks on a 'building tools' store (like home depot), and on the label said, among other things in chinese and english, non medical.
In this KN95 Masks Explained mentions
...
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Progress of the FDA's review of RMAT products
The U.S. FDA appears to have five shortcut regulatory approval ways, as follows;
(1) Accelerated Approval
(2) Priority Review
(3) Fast Track
(4) Breakthrough Therapy
(5) RMAT：Regenerative Medicine ...
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Clinical implications of observed faster mutation rate of SARS-CoV-2 in group quarantine?
This was posted as a rapid communication on WHO's bulletin:
28 specimens of COVID-19 patients from the cruise with a 3 week quarantine
period were collected in USA and Japan from February 10 to ...
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Have any regulatory agencies announced they would allow live Covid-19 human challenges (for vaccine testing purposes)?
It's been mentioned to me in the discussion on another question that the following proposal has been advanced (in a medical journal):
Controlled human challenge trials of SARS-CoV-2 vaccine ...
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What happens when a candidate drug becomes an ATMP？ What's the list of ATMPs?
According to The Alliance for Regenerative Medicine, the following six Tissue-Engineered Products are available in Europe.
Spherox
Novocart 3D
ReNovaCell
ReGenerCel
Vergenix FG
Vergenix-STR
I ...
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Are there websites with clinical trial reports freely available for download?
I'm a translator, and I'm currently translating clinical trial reports, Russian to English. I wonder if there are depositories of freely available clinical trial reports, with all appendixes and all ...
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