FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Therapies Engineering Production FDA 59

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. 1 With this growth comes increased demands for laboratory services at all steps across the development process. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.

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Laboratories Assay Development Small Molecule Drug Development 52

Broad Institute

JUNE 30, 2023

LipocyteProfiler builds on the concept of image-based profiling that was first introduced in the context of morphology mapping by Cell Painting, a high-content imaging assay developed by Broad institute scientist and Imaging Platform senior director Anne Carpenter.

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Small Molecule Cell Based Assays Disease Assay Development 105

Drug Target Review

OCTOBER 10, 2024

Developing cell therapies exclusively with healthy donor material introduces substantial risks that can hinder clinical translation and jeopardise the entire program. These risks stem from the fundamental biological differences between healthy and diseased cells, impacting various stages of development.

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Therapies Immune Response Clinical Trials Disease 52

The Pharma Data

JANUARY 27, 2021

TD-0148A is a potential novel new therapy to treat debilitating psychiatric disorders with high unmet need, such as treatment resistant severe depression and post-traumatic stress disorder. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect.

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FDA Synthetic Chemistry Assay Development Treatment 52

Agency IQ

JULY 21, 2023

subsequent superior/inferior supportive care, lifestyle changes, and/or use of additional therapies). In fact, the FDA estimates that the accelerated approval program is responsible for access to life-saving anti-cancer therapies a median of 3.4 years before they would have been available otherwise.

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FDA Clinical Trials Treatment Trials 40

Agency IQ

FEBRUARY 2, 2024

Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care. Briefly addressing companion diagnostics, the guideline advises that sponsors consider co-development of a companion diagnostic and the medicinal product.

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Clinical Trials Trials Treatment Disease 40