Agency IQ

DECEMBER 1, 2023

While the previous version stated that patients with kidney or liver dysfunction should be enrolled as long as the pharmacokinetics (PK) for the drug in such patients is “adequately understood,” the new guidance is phrased to indicate that, moving forward, the PK in these patients should be understood.

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Agency IQ

DECEMBER 11, 2023

Older adults: While certain age-associated factors like comorbidities, age, and weight can be adjusted using standard clinical pharmacology methods; reviewers have noted that these factors do not entirely adjust for the differences we see in older patient populations.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Once metabolized, which occurs quickly with a half-life of approximately 1.5

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Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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