The FDA set up a new Web page to provide postmarket drug safety information to patients and providers.
The Food and Drug Administration (FDA) set up a new Web page to provide postmarket drug safety information to patients and providers, American Medical News (11/17/08) reported. The Web site, http://www.fda.gov/cder/drugsafety.htm, was created under the requirements of the FDA Amendments Act of 2007 and enacted last fall to correct drug safety problems.
The site provides links to a variety of information, including drug labeling; medications that have risk evaluation and mitigation strategies; FDA-required postmarket studies and clinical trials of approved products; registry of federally and privately supported clinical trials; and the latest safety information. Included are an index to drug-specific information, drug safety announcements, medical product safety information from MedWatch, and new safety information identified by the Adverse Event Reporting System. Site users also can link to MedWatch, information about warnings and recalls, regulations and guidance documents, general health information, and consumer and professional articles about using medicines safely.
FDA grants 510(k) clearance to chemiluminescence-based immunoassay
Published: January 10th 2025 | Updated: January 10th 2025The automated chemiluminescence-based immunoassay has received clearance for free testosterone, providing enhanced diagnostic options to a multitude of conditions.
Read More