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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Common CMC Issues for Phase 1 IND Study. The workshop is also discussed in Cell & Gene here and here.

Therapies

Therapies Engineering Production FDA

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

JULY 21, 2023

BY RACHEL COE, MSC JUL 18, 2023 11:14 PM CDT Oncology endpoints: The growing pains of an evolving field FDA approval of a drug or biologic relies on whether there is “substantial evidence” of safety and effectiveness derived from “adequate and well-controlled clinical investigations” according to the Federal Food, Drug, and Cosmetic (FD&C) Act.

FDA

FDA Clinical Trials DNA Treatment

Drug Discovery Digest

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

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