Conversations in Drug Development Trends

FEBRUARY 21, 2024

To proactively manage subject expectations, we provide participants with the following: Dry restrooms No definitive stopping date Dietary requirements 24/7 collection of urine & fecal matter Blood sample collection 2. This process involves a careful assessment of medical history and daily bowel habits.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

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Agency IQ

OCTOBER 6, 2023

While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. If a drug was previously approved for cancer, but is now approved for a cardiology condition, it would not be considered novel.

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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

DECEMBER 1, 2023

One noteworthy addition is the statement that “Sponsors are encouraged to use quantitative clinical pharmacology approaches that leverage all available information for selection of dosing regimen(s) to be evaluated in clinical trials.”

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Agency IQ

JUNE 16, 2023

fit in this definition. The change in fees will allow FDA to maintain an adequate color certification program as required by section 721(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. The proposed amendments will update FDA regulations to incorporate the statutory amendments.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

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