Conversations on Cancer: Patient first = Project Facilitate

Join the FDA Oncology Center of Excellence for a compelling Conversation on Cancer focused on Project Facilitate, a dedicated resource designed to streamline access to investigational therapies for patients facing life-threatening cancers. When standard treatment options are exhausted and clinical trial enrollment isn't possible, FDA's Expanded Access Program offers a critical pathway for patients to access investigational drugs, biologics, or medical devices that have not yet received FDA approval. However, navigating the single-patient Investigational New Drug (IND) application process can be daunting, particularly for oncology healthcare providers without extensive regulatory experience. Project Facilitate serves as a single point of contact, offering expert guidance to help oncology professionals successfully submit expanded access requests and bring hope to their patients in urgent need.

Pharmacovigilance in Practice   From Safety Signals to Regulatory Action 1080
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Pharmacovigilance in Practice From Safety Signals to Regulatory Action 1080

CDER & CBER All Hands: Implementing the FDA's Plausible Mechanism Framework
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CDER & CBER All Hands: Implementing the FDA's Plausible Mechanism Framework

Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing

FDA Direct: Combating Rare Diseases at the FDA
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FDA Direct: Combating Rare Diseases at the FDA

OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
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OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products

Oncology Nurses - The Frontliners in Oncology
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Oncology Nurses - The Frontliners in Oncology

FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine
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FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine

Advancing Real-Time Clinical Trials
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Advancing Real-Time Clinical Trials

Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
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Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims

CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
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FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)

FDA Direct: The Power of Real-Time Clinical Trials
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FDA Direct: The Power of Real-Time Clinical Trials

VRBPAC -- May 28 Meeting
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VRBPAC -- May 28 Meeting

ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video
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ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video

FDA Direct: The Power of Real-Time Clinical Trials
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FDA Direct: The Power of Real-Time Clinical Trials

CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

CBER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CBER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

Know Your Nutrition
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Know Your Nutrition

CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products