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- FDA policy allowing compounding of unapproved peptides raises safety and development concernsThe Department of Health and Human Services recently approved the compounding of six peptide products that have not received FDA approval. This move expands the list of bulk substances that traditi…
- FDA issues draft guidance to streamline approval of personalized gene therapiesThe FDA released a draft guidance that outlines an "adapted pathway" for regulating gene‑edited medicines. The new framework is intended to speed the development and approval of personalized gene t…