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The CEO that founded Liveyon, a manufacturer and distributor of stem cell-derived products tied to bacterial infections requiring hospitalization, has plead guilty to felony distribution of unapproved drug products, the Department of Justice (DOJ) announced. Read More
The FDA has finalized guidance on the Voluntary Malfunction Summary Reporting (VMSR) program that allows manufacturers to submit medical device reports (MDRs) for certain low-risk devices to the agency on a quarterly basis instead of sending individual malfunction reports. Read More
Sponsors appear more informed and prepared than sites for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company. Read More
This edition of Quick Notes provides approval notes on treatments for hypoparathyroidism, prurigo nodularis, primary biliary cholangitis and graft-versus-host disease. Read More