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Media Summary: The Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) hosts a The committee will discuss a biologics license application. Have a question for our presenters or panelists? Please email OTPEvents@

Fda Roundtable On Cell And - Detailed Analysis & Overview

The Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) hosts a The committee will discuss a biologics license application. Have a question for our presenters or panelists? Please email OTPEvents@ New half-hour, non-invasive procedure uses patients' own stem A Transformative Year: A Conversation with the This presentation provided guidance on nonclinical assessment of

Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration ( From William bill Gruner declared no financial interest and is cheered to participate in the Anything that impugns that is just not acceptable” – Dr. Peter Marks, Director, Center for Biologics Evaluation & Research (CBER) ...

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FDA Roundtable on Cell and Gene Therapy
FDA Roundtable on Cell and Gene Therapy
LIVE: FDA Hosts Cell and Gene Therapy Roundtable
75th Cellular, Tissue, and Gene Therapies Advisory Committee
Advancing Pediatric CGT Clinical Trials: Scientific, Ethical, Regulatory & Practical Considerations
FDA Wary of Pain Relief Procedure Using Stem Cells
FDA Roundtable
FDA-NIH 2024 | D1S11 - Nonclinical Assessment of Cell and Gene Therapy (CGT) Products to Support....
Updates on FDA’s Efforts to Accelerated Advances in Cell and Gene Therapy
Roundtable on PMTA Submissions for ENDS Products
Expert Panel with the FDA on Talc
How the FDA Strengthens Industry Collaboration
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FDA Roundtable on Cell and Gene Therapy

FDA Roundtable on Cell and Gene Therapy

Captioning Link: https://bit.ly/4dQaNaz.

FDA Roundtable on Cell and Gene Therapy

FDA Roundtable on Cell and Gene Therapy

This exclusive

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LIVE: FDA Hosts Cell and Gene Therapy Roundtable

LIVE: FDA Hosts Cell and Gene Therapy Roundtable

The Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) hosts a

75th Cellular, Tissue, and Gene Therapies Advisory Committee

75th Cellular, Tissue, and Gene Therapies Advisory Committee

The committee will discuss a biologics license application.

Advancing Pediatric CGT Clinical Trials: Scientific, Ethical, Regulatory & Practical Considerations

Advancing Pediatric CGT Clinical Trials: Scientific, Ethical, Regulatory & Practical Considerations

Have a question for our presenters or panelists? Please email OTPEvents@

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FDA Wary of Pain Relief Procedure Using Stem Cells

FDA Wary of Pain Relief Procedure Using Stem Cells

New half-hour, non-invasive procedure uses patients' own stem

FDA Roundtable

FDA Roundtable

A Transformative Year: A Conversation with the

FDA-NIH 2024 | D1S11 - Nonclinical Assessment of Cell and Gene Therapy (CGT) Products to Support....

FDA-NIH 2024 | D1S11 - Nonclinical Assessment of Cell and Gene Therapy (CGT) Products to Support....

This presentation provided guidance on nonclinical assessment of

Updates on FDA’s Efforts to Accelerated Advances in Cell and Gene Therapy

Updates on FDA’s Efforts to Accelerated Advances in Cell and Gene Therapy

Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (

Roundtable on PMTA Submissions for ENDS Products

Roundtable on PMTA Submissions for ENDS Products

The purpose of the

Expert Panel with the FDA on Talc

Expert Panel with the FDA on Talc

Expert Panels with the

How the FDA Strengthens Industry Collaboration

How the FDA Strengthens Industry Collaboration

During

Why the FDA’s approval of revolutionary sickle cell gene therapy is a ‘big deal’

Why the FDA’s approval of revolutionary sickle cell gene therapy is a ‘big deal’

Sickle

May 20-21, 2025 Meeting of the Oncologic Drugs Advisory Committee (ODAC) - Day 1

May 20-21, 2025 Meeting of the Oncologic Drugs Advisory Committee (ODAC) - Day 1

Next slide this table includes the

Yao-Yao Zhu On Working with the FDA | Cell & Gene Therapy Regulatory Affairs Summit

Yao-Yao Zhu On Working with the FDA | Cell & Gene Therapy Regulatory Affairs Summit

In the lead-up to the

FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy

FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy

FDA

What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago

What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago

This is Episode 4 of "

Vaccines and Related Biological Products Advisory Committee Meeting

Vaccines and Related Biological Products Advisory Committee Meeting

From William bill Gruner declared no financial interest and is cheered to participate in the

Preview: CBER Director Peter Marks Discusses FDA's Credibility at ARM's 2020 Meeting on the Mesa

Preview: CBER Director Peter Marks Discusses FDA's Credibility at ARM's 2020 Meeting on the Mesa

Anything that impugns that is just not acceptable” – Dr. Peter Marks, Director, Center for Biologics Evaluation & Research (CBER) ...

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