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 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FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far Last month, the FDA published a new draft guidance document on diversity action plans.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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Agency IQ

FEBRUARY 2, 2024

The European Commission also implemented its Mission on Cancer , which aims to further cancer research and innovation through funding in the same areas as the cancer plan. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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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FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances.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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FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).

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