Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. FDORA also directed the FDA to convene a meeting.

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Agency IQ

AUGUST 16, 2024

Lykos also registered an additional open-label Phase 1 pharmacokinetics study of midomafetamine and metabolites in patients with moderate hepatic impairment to understand if a dose adjustment is necessary in that population. This study is planned to start in late 2024 and conclude in late 2025. and in Europe.

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Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. A year later, a similar workshop was conducted that included biologics and nonclinical models for efficacy, as well as modeling and simulation for dose-finding and dose optimization trials design.

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Agency IQ

FEBRUARY 2, 2024

See AgencyIQs analysis of a workshop on novel methodology qualification.] The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more.

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The Premier Consulting Blog

FEBRUARY 11, 2025

These approaches are discussed in multiple workshops held by the Agency and its partners (e.g., Some innovative approaches that sponsors should consider include: Pharmacokinetic studies using an N-of-1 or single-case experimental design. Innovative approaches and FDA initiatives In addition to the special designations available (e.g.,

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