Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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Agency IQ

DECEMBER 1, 2023

The FDA has said in court filings that it plans to make a decision about Florida’s prescription drug importation proposal in December, and recently pushed back a response date related to a similar plan from Colorado. This is already proving to be one of the FDA’s most-opposed actions in years. to include devices.

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Agency IQ

OCTOBER 27, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to include devices.

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