Federal Register notice: FDA releases a draft guidance entitled Quality Considerations for Topical Ophthalmic Drug Products.
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7.
Federal Register notice: FDA sends to OMB an information collection extension entitled Importation of Prescription Drugs from Canada.
FDA clears an InfoBionic 510(k) for its MoMe ARC, the companys third-generation remote electrocardiogram monitoring device.
FDA clears a Heidelberg Engineering 510(k) for its ANTERION platform, which the company says is designed to transform anterior segment diagnostics and...
The CDER Office of Prescription Drug Promotion says it plans to research adherence potential and patient preference in prescription drug promotion.
FDA publishes a draft guidance on quality considerations for ophthalmic drug products indicated for topical delivery in and around the eye.
Citing inspection findings that need to be resolved, FDA sends Alvotech a complete response letter for its BLA for AVT04, a biosimilar of Janssens Ste...
