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Online First: Effect of #ProjectOrbis participation by the Swiss regulator Swissmedic on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis #cancerdrugs thelancet.com/journals/lanon…

FDA medical oncologist Timil Patel, MD is joining the DTRA gang for a Tues chat to discuss recent #asco24 abstract re: adoption of decentralized trial elements in cancer clinical trials during pandemic. CTTI & FDA collected data from research sponsors h/t Amir Kalali, MD 🌐 1/n

⭐️Honored to meet with the visionary Dr. Rick Pazdur whose insights have always inspired me through all these years. It was such an incredible ASCO !🏆 Working in oncology clinical trials now is amazing, with advancements in #PrecisionMedicine, immunotherapy, ADCs, & much

Reflections and Roadmaps: Career Development Beyond the FDA-AACR Oncology Educational Fellowship - via Clinical Cancer Research ✔️ Transformative experience ✔️ Regulatory deep dive ✔️ Mock ODAC 💯 Unique opportunity! aacrjournals.org/clincancerres/… Timil Patel, MD Jennifer Gao #MedEd #OCEProjectSocrates

Check👇 Reflections and Roadmaps: Career Development Beyond the FDA-AACR Oncology Educational Fellowship Hem-Onc Fellows Network FDA Oncology Timil Patel, MD Jennifer Gao Chris Chen, MD Yasmin Kadry UAMS Myeloma Center Clinical Cancer Research ➡️ aacrjournals.org/clincancerres/… A great program, highly recommended

Career Development Beyond the FDA Oncology-AACR Oncology Educational Fellowship Clinical Cancer Research Timil Patel, MD Jennifer Gao oncodaily.com/95185.html #Cancer #CancerResearch #FDAOncology #AACR #OncoDaily #Oncology

Beginning tomorrow, the Cancer Cabinet that President Donald J. Trump created to end cancer as we know it - will host a series of virtual conversations highlighting key actions driving progress on priorities for the #BidenCancerMoonshot. Join us! whitehouse.gov/cancermoonshot…

A Clinical Cancer Research article highlights how the FDA-AACR Oncology Educational Fellowship helped four alumni develop their career trajectories. Applications for the next class of fellows are open through Aug 1. Learn more: bit.ly/3SljsIG #AACRSciencePolicy Timil Patel, MD Samer Al Hadidi, MD,MS,FACP

FDA approves lazertinib in combination with amivantamab-vmjw for locally advanced or metastatic non-small lung cancer with specific EGFR mutations. fda.gov/drugs/resource… #OCENewsBurst #lcsm

Its here! U.S. FDA guidance on Conducting Clinical Trials With Decentralized Elements is out! Protocols should specify whether - Telehealth visits is appropriate - Local health care providers can conduct study visits fda.gov/regulatory-inf…

NEW 📣Final FDA Guidance on decentralized #clinicaltrials is out! Covers local labs, imaging, procedures; local healthcare providers; telehealth; informed consent; inv product delivery/accountability; & data mgmt. #MedTwitter #regulatory #DrugDevelopment fda.gov/regulatory-inf…

Proud of the efforts of Project Asha “Quad Countries Launch Cancer Moonshot Initiative to Reduce the Burden of Cancer in the Indo-Pacific”. The power of leadership coming together to make a difference. President Donald J. Trump Narendra Modi PMO India whitehouse.gov/briefing-room/…

FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy. fda.gov/drugs/resource… #OCENewsBurst

FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer without EGFR mutations or ALK rearrangements. fda.gov/drugs/resource… #OCENewsBurst #lcsm

Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug - via Journal of Clinical Oncology. Authors Gautam Mehta, MD Rick Pazdur ascopubs.org/doi/full/10.12… #OCEPublications #OCEProjectConfirm

FDA Oncology Center and other FDA staff as well as Dr. Robert M. Califf celebrated Dr. Richard Pazdur’s ongoing 25 years of service at the agency during an FDA Fall Tailgating event on Oct. 17.

Recently we welcomed more than 40 fellows to FDA—in collaboration with ASCO—for an educational workshop, now in its 10th year. An additional almost 100 fellows joined virtually. What a great group! #OncEdFellows #OCEProjectSocrates #MedEd

#OncTwitter fellows, hope to see you there! Apply by 12/4! #MedEd #regulatory

.Laleh Amiri-Kordestani, MD and Eric Winer, MD moderate a special session SABCS to better understand the process of U.S. FDA FDA Oncology drug review and approval process. Smilow Cancer Hospital Yale School of Medicine YaleBreastCancer

The newly-established Raj and Indra Nooyi Cancer Research Fund will help Yale Surgery researchers led by @MehraGolshan reduce the global burden of #breast #cancer through early detection and advanced #treatment strategies with reduced toxicity: brnw.ch/21wPLmV