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topicbiologics-regulation
Federal Register documents tagged biologics-regulation. Each entry is scored 1-5 for compliance materiality and dated for any comment or effective-date deadlines.
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§ 01 Agencies issuing on this topic
§ 02 Recent documents
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Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
FDA announces the availability of a draft guidance describing streamlined approaches to general toxicology and other nonclinical safety assessments for certain oncology biologics and conjugated products. The draft is intended to reduce unnecessary animal studies, including non-human primate use, while informing sponsors’ development programs for cancer therapies.
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