Agency IQ
FEBRUARY 23, 2024
BY CHELSEY MCINTYRE, PHARMD , KARI OAKES 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.
FDA Law Blog: Drug Discovery
MARCH 13, 2023
Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?
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FDA Law Blog: Drug Discovery
JULY 17, 2024
An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.
On Medicine
SEPTEMBER 11, 2023
Firstly, we delivered a co-development phase involving focus groups, interviews and/or workshops, engaging 40 lived experience and professional stakeholders to develop the intervention components. We also held a final feasibility workshop to gain the perspectives of different stakeholders and to explore future directions.
FDA Law Blog: Drug Discovery
MAY 4, 2023
Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.
Vial
JUNE 18, 2024
The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Representation, Underrepresentation & Diversity in Clinical Trials Studies indicate a need to increase patient accessibility to clinical trials.
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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