Theqmnweeklybulletin

Sept. 22, 2017

Vol. 9 No. 38

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FDA Moves Against Internet Drug Retailers

The FDA has cracked down on a host of operators peddling prescription drugs online, claiming the vendors are selling the drugs without a prescription, or marketing the drugs in a way that is not approved by the agency, or both. Read More

FDA Shoots Down Imports From South Korean Drugmaker

The FDA blocked imports from a South Korean manufacturer of over-the-counter medical products after agency inspectors reported violations of current good management practices. Read More

Claims for Dynavision D2 Exceeded Approved Indications, FDA Says

An Ohio company violated federal regulations for medical devices by making claims for its product that were not approved by the FDA, the agency said in a warning letter. Read More

FDA Extends Datascope Field Correction to Class I Recall

The FDA expanded Datascope/Maquet’s June 20 voluntary worldwide field correction of certain intra-aortic balloon pumps and designated it a Class I recall. Read More