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FDA publishes a draft guidance on quality considerations for ophthalmic drug products indicated for topical delivery in and around the eye.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...
Federal Register notice: FDA determines that Novartis Pharmaceuticals Mekinist (trametinib dimethyl sulfoxide) tablets (1 mg) were not withdrawn for s...
Federal Register notice: FDA sends to OMB an information collection extension entitled Allegations of Regulatory Misconduct Voluntarily Submitted to t...
PhRMA suggests that FDA revise a draft guidance on QTc labeling to incorporate an International Council on Harmonization guideline.
