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FDA publishes an updated final guidance on the Breakthrough Device program.[ Price : $8.95]
FDA grants Attune Medical a de novo marketing authorization for its ensoETM device and its use to reduce the likelihood of ablatio...[ Price : $8.95]
Federal Register notice: FDA establishes a docket to solicit stakeholder comments to assist the agency in developing a Quality Man...[ Price : $8.95]
FDA publishes a guidance on using forms FDA 3988 and 3989.[ Price : $8.95]
FDA says exploring how artificial intelligence can play a role in its regulatory operations is a top strategic goal of its just-re...[ Price : $8.95]
FDA publishes draft guidances to support clinical and non-clinical testing in premarket submissions for medical devices with a wei...[ Price : $8.95]
The Federal Trade Commission issues a policy statement, which is supported by FDA, warning brand-name pharmaceutical companies tha...[ Price : $8.95]
FDA approves updated and revised labeling for Mercks Temodar under the Oncology Center of Excellence Project Renewal pilot program...