Questions tagged [fda]
The fda tag has no usage guidance.
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What federal or state law requires two people during Patient Lift transfers?
Where can I find the regulations or laws that says the number of people required to transfer a patient? I found this FDA Safety Guide booklet, but I did not find a federal or state law. Does this ...
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Can a US state ban a drug that is approved by the FDA?
The more common scenario nowadays is for a US state to "legalize" a drug that is illegal Federally, namely cannabis. This scenario has been well-researched and it is well-settled that the ...
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What is the correct ingredient labeling order for cosmetics to comply with the FDA?
On 21 CFR 701.3, FDA Summary of Cosmetics Labeling Requirements, Declaration of Ingredients, it states that "ingredients must be declared in descending order of predominance."
What is the ...
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Can I sell an unscheduled compound as a recreational drug in the USA?
From the Oxilofrine Wikipedia page:
Legal Status US: Unapproved "New Drug" (as defined by 21 U.S. Code § 321(p)(1)). Use in dietary supplements, food, or medicine is unlawful; otherwise ...
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What determines the legality of whether a non-controlled substance can be included in food?
If there was a food or chemical substance that was not listed as a controlled substance either federally or at the state level, and it is never explicitly mentioned in any FDA food guidelines, does ...
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Does FDA require Clinical Research Companies/labs required to use relational/non-relational databases to store or document clinical trial data?
Are American Clinical Research Companies or laboratories doing analysis for clinical trials required to use relational databases or non-relational databases or Relational Database Management Systems ...
- 311
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Does FDA's "compassionate use" program allow doctors to prescribe drugs to themselves under Emergency Use?
Does the "compassionate use" program allow doctors to prescribe drugs for themselves that have been approved under an FDA emergency use authorization?
user46398
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How are food products containing partially hydrogenated oils (PHOs) still being sold?
All food products containing partially hydrogenated oils (PHOs) were banned from being sold in stores in the US starting January 1st, 2021:
To allow for time for reformulation, the agency is ...
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Safety and effectiveness have not been established for _
If an FDA approval says the following for treatment with a medical device, does this mean a doctor absolutely cannot treat a patient (with any of the conditions) with the device? Or does it just mean ...
- 225
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How to interpret the US law for Emergency Use Authorization
Does the list of requirements in this law below mean that the Secretary must follow all requirements to satisfy the EUA or it's up to the secretary which ones are required?
https://uscode.house.gov/...
- 111
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Is it legal to sell food or supplement products online in unlabeled packaging?
As I understand it, the FDA requires labeling with specific information for food and supplement products in most cases, and steep potential penalties for "misbranding" if required ...
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Can an employer mandate an EUA-approved vaccine?
Liberal political commentator Matt Yglesias just tweeted this:
I’m not an expert in Vaccine Law.
But the military requires a lot of vaccinations but says it can’t require the Covid vaccines because ...
1
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98
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Can the need for FDA authorization of a tool to find infectious people be bypassed by labeling?
Background. OTC (over-the-counter, i.e. not requiring a prescription) rapid antigen covid-19 tests are the tests which detect pieces of viral proteins using lateral flow paper strips. Infected ...
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Why is it difficult to import 5-HTP (a form of Tryptophan) into some countries? [closed]
5-Hydroxytryptophan(WP) is sold in various places around the world as a dietary supplement that may boost serotonin levels, with possible benefits as a sleep aid, antidepressant, appetite suppressant, ...
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Can POTUS make FDA approve a drug (such as hydroxychloroquine), or make it available over the counter?
President Trump is known to have taken hydroxychloroquine (HCQ) as a prophylactic against COVID-19.
Some prominent medical scientists also came out in support of HCQ for outpatients (as opposed to ...
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