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. Ethical considerations are critical to clinical pharmacology studies as these studies generally don’t provide a direct clinical benefit to the patient and the vulnerable population involved.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes. Engaging with regulatory agencies early and continuously is essential.

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Agency IQ

AUGUST 11, 2023

Quick background: Optical Character Recognition (OCR) technology systems convert physical, printed, or scanned documents into machine-readable text, as defined by IBM. These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more. What’s next?

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Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. In addition, the studies collected limited clinical laboratory data to inform the safety profile and did not systematically document adverse events that could contribute to abuse potential.

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The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod.

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Agency IQ

AUGUST 9, 2024

FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far Last month, the FDA published a new draft guidance document on diversity action plans. While the new version of the guidance is greatly expanded as compared to an earlier version from 2022, it has left plenty of important questions unanswered.

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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.

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