Agency IQ

MARCH 1, 2024

Per a statement from a 2014 shutdown (which has been scrubbed from the FDA’s web pages, but was captured in this FDA Law Blog article ), the agency “will not be able to accept any regulatory submissions… that require a fee payment and that are submitted during the lapse period.” What are the impacts for regulated industry?

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Government FDA Biosimilars Regulations 40

Agency IQ

SEPTEMBER 29, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014. The final rule will amend the administrative destruction provisions in 21 CFR 1.94 to include devices.

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. 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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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014. The final rule will amend the administrative destruction provisions in 21 CFR 1.94 to include devices.

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FDA Science Regulations Production 40