FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women

FDA reviewed many published research studies, including both nonclinical and clinical data. Nonclinical Studies We reviewed published nonclinical studies showing that early exposure to anesthetic drugs can produce adverse neurotoxic effects in different species, including simple nematodes, rats, and nonhuman primates.1-20 The studies demonstrate that the use of anesthetic drugs during the period of rapid…

FDA Drug Safety Communication: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer

We systematically reviewed published epidemiological studies evaluating the risk of bladder cancer with pioglitazone use. Some studies found an increased risk of bladder cancer with pioglitazone use and others did not. The following studies are presented to illustrate the inconsistent findings among all reviewed studies. The manufacturer of pioglitazone, Takeda Pharmaceuticals, conducted a 10-year prospective…

Non-Inferiority Clinical Trials

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Advisory to Drug and Dietary Supplement Manufacturers, Compounding Pharmacies and Distributors of Excipients and Dietary Ingredients – FDA Detects High Levels of Peroxide in Crospovidone

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Drug Trials Snapshots: EXONDYS 51

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for…