Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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Agency IQ

SEPTEMBER 29, 2023

That will have meant that FDA flagrantly missed its deadline to issue a guidance document related to medical countermeasure submissions and the use of Drug Master Files for platform technologies, which was due June 24, 2022. FDA is also due to revise 24 other guidance documents at that time. This is what OIRA is currently reviewing.

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Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. FDA is also due to revise 24 other guidance documents at that time. AgencyIQ November 18 Shutdown (?)

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Agency IQ

JUNE 29, 2023

We’ve also included documents that are actively under White House review – a process which often takes several weeks (or months) to conclude. 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.

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Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The final rule will amend the administrative destruction provisions in 21 CFR 1.94 the drug and device) of the combination product.

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The Pharma Data

MAY 15, 2021

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