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Federal Register notice: FDA releases a draft guidance entitled Quality Considerations for Topical Ophthalmic Drug Products.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Importation of Prescription Drugs from Cana...[ Price : $8.95]
FDA clears an InfoBionic 510(k) for its MoMe ARC, the companys third-generation remote electrocardiogram monitoring device.[ Price : $8.95]
FDA clears a Heidelberg Engineering 510(k) for its ANTERION platform, which the company says is designed to transform anterior seg...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says it plans to research adherence potential and patient preference in prescriptio...[ Price : $8.95]
FDA publishes a draft guidance on quality considerations for ophthalmic drug products indicated for topical delivery in and around...[ Price : $8.95]
Citing inspection findings that need to be resolved, FDA sends Alvotech a complete response letter for its BLA for AVT04, a biosim...