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FDA says it wants to give institutional review boards some greater flexibility to waive or alter informed consent requirements und...[ Price : $8.95]
Harvard Medical School researchers outline several steps that FDA and Congress could take to increase the number of biosimilars av...[ Price : $8.95]
FDA clears a Lumendi 510(k) for its DiLumen EIP technology with suture loops placed in the skirt along the trailing edge of the fo...[ Price : $8.95]
FDA accepts for review an Ardelyx NDA for tenapanor for treating patients with irritable bowel syndrome with constipation.[ Price : $8.95]
FDA warns US Vascular about Quality System and Medical Device Reporting violations in its production of VascuLab devices used in v...[ Price : $8.95]
FDA warns StemGenex about multiple violations in its production of a stromal vascular fraction product.[ Price : $8.95]
FDA describes professional promotion research it wants to conduct about oncology drug disclosures.[ Price : $8.95]
The Stericycle Recall Index for the third quarter of 2018 shows an increase in drug recalls and a decrease in medical device recal...