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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Drug Discovery

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Forging a Path Forward for Substance Abuse Potential Studies With the Cross-Company Abuse Liability Council By Beatrice Setnik, PhD

Alta Sciences

The CCALC is a grassroots organization that was founded by several pharmaceutical industry members seeking clarity around the conduct of abuse and dependence potential assessments for novel drugs in development. This was in 2006, at a time when the FDA guidances on these topics had not yet been published.

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How Real-World Data is Helping Speed Oncology Drug Development

Drug Channels

Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. To learn more, visit the Ontada website. This Feed is for personal non-commercial use only.

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Ageing and cancer-causing gene: researchers uncover a link

Drug Target Review

Prochownik, delved into the dual role of the Myc gene in both cancer development and ageing. The findings highlight the gene’s complex functions, opening up new avenues for cancer therapy and raising important considerations for future drug development. Academic Press; 2006 [cited 2023 Jul 27]. References Chi V.

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Six Trends to Watch in the New Healthcare Economy

Drug Channels

Karen examines trends in drug development, pricing, and healthcare. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. She also serves as co-chair of Maintenance and Control at the NCPDP.

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Informa Connect’s Access USA

Drug Channels

Drug Channels, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@drugchannels.net). Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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The evolution of cell therapy to address unmet medical needs

Drug Target Review

Mr Culley served from 2007 to 2010 as Mast’s Chief Business Officer and Senior Vice President, from 2006 to 2007 as Mast’s Senior Vice President, Business Development, and from 2004 to 2006 as Mast’s Vice President, Business Development. SVRA) in April 2017. Mr Culley served on the Board of Orphagen Pharmaceuticals, Inc.