Newsletter | June 27, 2024

06.27.24 -- Psychedelic Community Reacts To FDA Critique Of Lykos' MDMA Studies

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OUTSOURCING MODELS

Assessing The 3 Cs: Does Your Organization Have The Foundation For Clinical Trial Success?

Guest Column | By Richard Malone, PharmD, MHA, Tanisha Patel, Vincent Puglia, and Renee Riggs

In part one of this series on the importance of culture, communication, and collaboration, the authors discuss building a strong company foundation and offer an assessment plan to identify strengths and weaknesses.

EMA’S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation

Article | By Karl-Heinz Loebel, Cencora PharmaLex

As the EU prepares to implement the new eCTD 4.0 standard for regulatory submissions, the European Medicines Agency (EMA) is taking steps to ensure a smooth transition for industry.

Guidelines For Response Criteria For Use In Oncology Trials

Infographic | Veristat, Inc.

Maintain consistency at sites and across sites, as well as limit any site bias, by using Response Evaluation Criteria in Solid Tumors (RECIST) when evaluating tumor response.

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The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good Manufacturing Practice (CGMP).

REGULATORY & COMPLIANCE

Psychedelic Community Reacts To FDA Critique Of Lykos' MDMA Studies

Guest Column | As told to Abby Proch, executive editor of guest columns, Clinical Leader

An FDA advisory committee rejected the validity of therapy-assisted MDMA clinical trials conducted for the treatment of PTSD. What does the committee’s vote mean for the pursuit of MDMA and other psychedelic therapies?

10 Tips For Enabling Better Sponsor-CRO Collaborations

Article | Oracle Life Sciences

By following these tips and investing in software tools, sponsors and CROs can optimize their partnerships and achieve greater success, leading to increased resource productivity and cost savings.

Dedicated Expertise In Your Fight Against Blood Cancers

Brochure | IQVIA Biotech

At IQVIA Biotech, our extensive oncology expertise, coupled with the ability to leverage IQVIA’s vast data, technology, and analytics resources, creates a clinical development partner perfect for you.

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Video | PCI Pharma Services

Our pharmaceutical packaging design department provides insightful packaging design and practical knowledge to deliver differentiated and cost-effective packaging solutions.

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