Questions tagged [regulatory-agencies]

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4
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1answer
127 views

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 ...
0
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0answers
23 views

Is there a standard between dermatologists not to inject numbing agents before laser treatments?

physicians often apply topical numbing agents (local anesthetics) such as Lidocaine+Prilocaine or Benzocaine+Lidocaine+Tetracaine (BLT) as a cream/ointment about 30 minutes before laser treatments. I ...
-2
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1answer
180 views

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/...
0
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1answer
51 views

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 ...
0
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1answer
40 views

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 ...
1
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1answer
93 views

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 ...
3
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0answers
58 views

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 ...
2
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1answer
51 views

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 ...
5
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3answers
2k views

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 ...
0
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1answer
45 views

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 ...
5
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1answer
260 views

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 ...
1
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1answer
48 views

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 ...
2
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0answers
197 views

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 ...
2
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1answer
192 views

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 ...
2
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1answer
104 views

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 ...
2
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1answer
206 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 ...
7
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1answer
101 views

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 ...
2
votes
2answers
182 views

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 ...
1
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1answer
88 views

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 ...
1
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0answers
297 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 ...
3
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0answers
29 views

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 ...
2
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0answers
37 views

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?
4
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1answer
62 views

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 ...
1
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1answer
39 views

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 ...
6
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0answers
56 views

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 ...