Questions tagged [regulatory-agencies]

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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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2 votes
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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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8 votes
1 answer
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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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-4 votes
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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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4 votes
1 answer
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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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-2 votes
1 answer
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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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1 answer
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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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1 vote
1 answer
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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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3 votes
0 answers
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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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2 votes
1 answer
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How do you know if an over the counter drug is safely processed and safe to use?

How do you know if an over the counter drug is safely processed and safe to use? I have not heard of the brand SDA Laboratories before, so tried searching online to see if it has any safety ...
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5 votes
3 answers
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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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0 votes
1 answer
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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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5 votes
1 answer
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Examples of infected disinfectants?

I've read in Pommerville's (2016) Fundamentals of Microbiology (p. 314) that contrary to popular belief that disinfectants kill all germs, there are examples of disinfectants that were contaminated ...
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1 vote
1 answer
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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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2 votes
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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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2 votes
1 answer
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Are false positives from Cellex’s Coronavirus antibody test systemic?

The FDA just approved the first antibody test for the Coronavirus, made by Cellex. The test has a significant false positive rate though (see here). Now for a lot of tests, false positives can be ...
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2 votes
1 answer
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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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2 votes
1 answer
225 views

"Mechanism of Action" (MOA) of medical drugs

I heard today from a doctor that the MOA for most drugs is actually 'unknown'! Wow, can this be true? I skimmed thru a pharmacology book, it looked pretty convincing but ultimately but didn't state ...
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7 votes
1 answer
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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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2 votes
2 answers
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Are drugs not approved by the FDA allowed to be prescribed?

There are lots of both prescription and generic drugs that are not approved at all for any reason in the United States. Some of this I have gathered is do to funding and historical reasons they were ...
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1 vote
1 answer
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Starch recommendation based on research

I am trying to identify daily recommended/suggested values based on research. I understand the values differ for each person and therefore no absolutes can be drawn but I am trying to identify ...
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1 vote
0 answers
369 views

Why is Ebrantil (Urapidil) not FDA approved?

Ebtrantil (Urapidil) is commonly used as an antihypertensive in Europe, also due to its additive interaction with other antihypertensives, and less likely to alter the heart rate compared to similar ...
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3 votes
0 answers
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Are canned/bottled foods acidified?

Two popular books ("Dropping Acid" by Dr. Jamie Koufman and "The Acid Watcher Diet" by Dr. Jonathan Aviv) claim that Title 21 of the FDA regulations require that all low-acid foods be acidified to ...
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2 votes
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Is there a database for the drug formulation?

I am interested in the antibody formulation (e.g. concentration, salts, pH, excipients, etc.). I wonder if there is a database for that?
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4 votes
1 answer
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What are we putting on our faces!?! Why don't we have an agency like the FDA approving/monitoring the safety of cosmetics?

"FDA does not approve cosmetics, although we do approve color additives used in cosmetics. It is the responsibility of cosmetic manufacturers to ensure, before marketing their products, that the ...
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1 vote
1 answer
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Are botox injections approved by the FDA to treat chronic migrraines?

Obviously, botox injections are used to treat wrinkles. I've also heard that it can treat a panoply of other things, including overactive-bladders and migraine prevention! Are botox injections FDA ...
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6 votes
0 answers
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Good Resoures for Learning/Studying GCP

Are there any widely accepted resources out there for studying/learning good clinical practices in the U.S. outside of the actual FDA webpage for the matter? Something an entry-level clinical ...
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