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The 1986 Animals (Scientific Procedures) Act regulates tests on any vertebrate animal and one kind of octopus, providing, say supporters, the best regulation of animal testing in the world.
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Typically, the agency has not regulated tests that are developed and performed by a single laboratory, as opposed to test kits that are sold to hospitals, laboratories and doctors.
The FDA regulates genetic tests that are sold as kits because they are considered to be medical devices.
The F.D.A. has typically refrained from regulating such tests, as opposed to test kits that are widely sold to laboratories, hospitals and doctor's offices.
In America, the Food and Drug Administration strictly regulates diagnostic testing for disease, but has been slow to extend its oversight to the public implications of genomics.With the federal authorities slow to react, state governments have begun to crack down.
In the USA, The Food and Drug Administration FDAA) has the authority to regulate genetic tests, but has only regulated the relatively small number of genetic tests sold to laboratories as kits.
Genentech, a developer of cancer drugs, petitioned the F.D.A. this month to regulate such tests.
Yet the move to regulate the tests is raising many issues.
Respiragene has not been approved by the Food and Drug Administration, which usually does not regulate such tests.
The case has raised questions about the degree to which the F.D.A. can or should regulate diagnostic tests.
But, for now, the agency has no specific plan to regulate the tests, in part because of lack of money.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com