August 1, 2024
Docket Number: FDA-1998-D-0019 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance for industry provides the Agency’s current thinking on how to […]
August 1, 2024
Our regulatory science programs are intended to provide FDA reviewers, and the wider drug development community, with the knowledge and the tools they need to evaluate […]
August 1, 2024
Español Drug Safety Podcast 6-1-2022 FDA Drug Safety Communication Drug Safety Communication (PDF – 197 KB) Due to safety concerns, the U.S. Food and Drug Administration […]
August 1, 2024
A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature1,2 through December 31, 2018, identified 305 cases of dental adverse events […]
August 1, 2024
Since 2015 when FDA first alerted the public about cases of underactive thyroid in infants receiving iodinated contrast media (ICM), several research studies evaluating this risk […]
August 1, 2024
(Reuters) – U.S. drugmaker Eli Lilly expects its blockbuster weight-loss drug to officially come out of shortage in the United States in coming days, Bloomberg News […]
August 1, 2024
Drinking more than three cups of coffee a day is linked to more rapid cognitive decline over time, results from a large study suggest. Investigators examined […]
August 1, 2024
Intensive glucose control doesn’t reduce mortality risk in critically ill patients when compared with conventional glucose control. Instead, it increases the risk for severe hypoglycemia by […]
August 1, 2024
STOCKHOLM — Current treatments for age-related macular degeneration (AMD) have proven effective and safe. However, these lifelong therapies involve frequent ocular injections. “It can be nerve-wracking […]
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