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- FDA advises early engagement and error prevention for BLA submissions, says CBER expertA CBER specialist shared practical guidance for companies preparing biologics license applications. The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can str…
- Study finds toxic metal exposure persists months after Maui wildfiresUniversity of Hawai‘i researchers examined urine samples from about 1,400 adults as part of the Maui Wildfire Exposure Study, one of the nation’s largest investigations of post‑fire health effects.…