Foreign Safety Data Sought By FDA Under Proposed Rule On Periodic Updates
Executive Summary
FDA's safety reporting rule would require drug and biologic sponsors to review any safety information acquired from a foreign regulatory authority to determine whether it should be reported to the agency
You may also be interested in...
Post-Market Safety Updates Replaced By “Periodic Benefit-Risk Evaluation Reports”
Draft guidance from FDA would adopt the International Conference on Harmonization’s periodic benefit-risk evaluation reports, which will offer sponsors the opportunity to provide updates on benefit information along with safety signals to the regulatory authorities.
IND Safety Reporting Rule Delayed After PhRMA Asks For More Harmonization
FDA has made the unusual decision to delay implementation of its new IND safety reporting rules, saying it will "exercise enforcement discretion" on the matter until Sept. 28 following a meeting with the Pharmaceutical Research and Manufacturers of America.
IND Safety Reporting Rule Delayed After PhRMA Asks For More Harmonization
FDA has made the unusual decision to delay implementation of its new IND safety reporting rules, saying it will "exercise enforcement discretion" on the matter until Sept. 28 following a meeting with the Pharmaceutical Research and Manufacturers of America.