FDA issues a final guidance on regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
CDER director Patrizia Cavazzoni says the Center will apply an intense focus to encourage the pharmaceutical industry to achieve quality management ma...
FDA Review posts the Federal Register notices for the week ending 2/21/2021.
Federal Register notice: FDA makes available a final guidance on premarket submissions for peripheral vascular atherectomy devices.
Federal Register notice: FDA makes available a draft guidance to help implement the ICH Q12: document on postapproval changes.
FDA clears an Overjet 510(k) for its Overjet Dental Assist artificial intelligence product that performs measurement for treating periodontal disease.
FDA accepts for priority review a BeiGene supplemental NDA for Brukinsa (zanubrutinib) for treating adult patients with marginal zone lymphoma.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide bioequivalence study design re...