Drug Discovery World

JULY 25, 2023

It has been a very busy period recently for paediatric drug development with the release of many guidance documents from two notable regulatory agencies. General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022.

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Agency IQ

FEBRUARY 2, 2024

The documents describe all the guidance documents that are under development and that may be published in a given year. Note: If a link no longer works, it is likely because OIRA has since cleared the document.) This is what OIRA is currently reviewing. Report will contain information specified in the commitment letter.

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Agency IQ

MARCH 1, 2024

Must also provide list of recommended documentation for AI contracts. Note: If a link no longer works, it is likely because OIRA has since cleared the document.) We’ve also included documents that are actively under White House review – a process which often takes several weeks (or months) to conclude. and the E.C.

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The Premier Consulting Blog

JUNE 18, 2023

A Modern Twist for the Gold Standard of Clinical Research The gold standard for clinical research intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).

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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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