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BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

The Pharma Data

These include in-vitro assays, cell-based phenotypic assays, safety pharmacology and efficacy, ADME toxicology, medicinal chemistry design, synthetic chemistry, and custom proteins and assay development capabilities.

FDA 52
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The hidden risks of over-reliance on healthy donor material

Drug Target Review

By promoting partnerships between biobanks, research institutions, regulators, and industry, we can create networks for information sharing, streamline access to diseased donor material, and facilitate joint research initiatives. Furthermore, fostering cross-industry collaboration is essential.

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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

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. Manufacturers who hold a biological license should report manufacturing deviations to the FDA per 21 CFR 600.14.