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Kalpen Patel Debarred by FDA

[ Price : $8.95]

Federal Register notice: FDA issues an order to permanently debar Kalpen D. Patel from providing services in any capacity to a per...

Data Monitoring Draft Guidance Released

[ Price : $8.95]

Federal Register notice: FDA releases a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.

FDA Warns 2 Firms Over Illegal Weight-Loss Drugs

[ 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...

ICH Draft Guide on Post-Approval Safety Data

[ Price : $8.95]

FDA publishes an ICH draft guideline on post-approval safety data that is available for comment.

Nanox Fatty Liver Detector Cleared by FDA

[ Price : $8.95]

FDA clears a Nanox AI 510(k) for HealthFLD, an artificial intelligence software that provides automated qualitative and quantitati...

FDA Getting Stricter on Cybersecurity Enforcement

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Former FDAer Naomi Schwartz says medical device companies must prioritize cybersecurity compliance to meet a stricter FDA enforcem...

FDA Issues Data Monitoring Committee Draft Guide

[ Price : $8.95]

FDA makes available a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.

Rule on Biologic Use of Master Files

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Federal Register notice: FDA issues a final rule to amend its regulations to address the use of master files by applications licen...

Priority Review for Lykos NDA for PTSD

[ Price : $8.95]

FDA accepts for priority review a Lykos Therapeutics NDA for midomafetamine capsules used in combination with psychological interv...

Draft Guide on Advanced Manufacturing Technologies

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FDA makes available a draft guidance entitled FDA Advanced Manufacturing Technologies Designation Program.