Safety Information For More Than 200 Drugs Posted Ahead Of Drug Watch Site
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA has posted drug-specific safety information for more than 200 products on a Center for Drug Research & Evaluation Research web page
You may also be interested in...
FDA Analysis Suggests Potential Pituitary Tumor Signal For Risperdal
Review of adverse event reporting system of pituitary tumors and antipsychotics shows the “vast majority” of tumors were with risperidone. Further data is needed before the signal would be posted on FDA’s drug safety watch list, the agency says. J&J will analyze the study and other data to determine if further studies are needed.
FDA Analysis Suggests Potential Pituitary Tumor Signal For Risperdal
Review of adverse event reporting system of pituitary tumors and antipsychotics shows the “vast majority” of tumors were with risperidone. Further data is needed before the signal would be posted on FDA’s drug safety watch list, the agency says. J&J will analyze the study and other data to determine if further studies are needed.
FDA "Drug Watch" Website To Include Three Categories Of Safety Information
The site will reflect information about serious adverse events, patient selection and monitoring, and risk minimization procedures, an FDA draft guidance states. Manufacturers will be notified "shortly before" information about a drug is first posted; agency suggests the site's information will not be used for promotional purposes.