2011, Assay Development and Regulations

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2011

Assay Development

Regulations

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. Similar to the OTAT town hall meeting in September, potency assay requirements and pitfalls were discussed.

Therapies

Therapies Engineering Production FDA

The essential role of recombinant phage display antibody libraries

Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. 2011 Oct 1;413(1):261–78. Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval.

Molecular Biology

Molecular Biology Pharmacokinetics Laboratories Animal Testing

Drug Discovery Digest

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

The essential role of recombinant phage display antibody libraries

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