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tag adam-standard

Q&A: A decade on, what’s next for CAR-T therapies?

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. Adam Zamecnik: We observed the ten-year anniversary of the first patient being successfully treated with a CAR-T therapy in May 2022. This interview has been edited for clarity and length.

Gene Therapy

Gene Therapy Gene Engineer Production

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

AUGUST 22, 2021

When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance. The publication of the Data Standards Catalog (DSC) followed.

Containment

Containment Bioavailability Cosmetics Packaging

Q&A: A decade on, what’s next for CAR-T therapies?

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

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