Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products." When finalized, this guidance will assist sponsors in implementing streamlined approaches for general toxicology, for nonclinical safety assessments of certain oncology pharmaceuticals. The guidance is intended to facilitate drug development for biological products and conjugated products for the treatment of cancer while avoiding unnecessary animal use. The recommendations in this draft guidance are informed by data analysis of general toxicology studies and practices developed during the COVID-19 pandemic to reduce use of non-human primates.
Official guideline text: FDA ↗
Brief written by VigiEye from the company's press release. Claims are the company's own. AI-assisted; check the source before acting.
RegulatoryCompany releaseBeyondSpring wins FDA Fast Track for plinabulin-docetaxel in post-immunotherapy NSCLC as cash dwindles to $0.6M
RegulatoryCompany releaseImricor starts US launch of NorthStar iMR system after paediatric FDA clearances
RegulatoryCompany releaseBeyond Air reports record $2.3M quarterly revenue as FDA reviews second-generation LungFit PH
RegulatoryCompany releaseFDA sets 10 March 2027 goal date for Intellia's one-time hereditary angioedema gene-editing therapy
RegulatoryCompany releaseBeyondSpring wins FDA Fast Track for plinabulin plus docetaxel in post-immunotherapy NSCLC
RegulatoryCompany release