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Federal Register notice: FDA issues an order to permanently debar Kalpen D. Patel from providing services in any capacity to a per...[ Price : $8.95]
Federal Register notice: FDA releases a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.[ Price : $8.95]
FDA warns Miami, FL-based US Chem Labs and Bronx, NY-based Helix Chemical that they are selling unapproved and misbranded versions...[ Price : $8.95]
FDA publishes an ICH draft guideline on post-approval safety data that is available for comment.[ Price : $8.95]
FDA clears a Nanox AI 510(k) for HealthFLD, an artificial intelligence software that provides automated qualitative and quantitati...[ Price : $8.95]
Former FDAer Naomi Schwartz says medical device companies must prioritize cybersecurity compliance to meet a stricter FDA enforcem...[ Price : $8.95]
FDA makes available a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.[ Price : $8.95]
Federal Register notice: FDA issues a final rule to amend its regulations to address the use of master files by applications licen...