Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Our rare disease team at Worldwide will be hosting a panel discussion webinar with patient advocates active in Rare Disease Day events to synthesize the most salient conversations taking place. See their conversation below and register for the webinar to hear more from these advocates!

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Fierce BioTech

JUNE 15, 2023

Since 2022, the cost of sequencing has substantially decreased, and innovative sequencing platforms have emerged, making whole genome DNA methylation profiling more cost-effective for clinical studies and diagnostic development.

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Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Check out this webinar on navigating the landscape of oncology clinical trials.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Combination products are defined by the FDA as : “A product comprised of two or more regulated components (i.e.,

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