FDA IND Safety Reporting Rule: New Types Of Data Must Be Submitted
Sponsors will have to provide new information to FDA under the agency’s final rule on investigational new drug safety reporting requirements.
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Drug Importation Is A High-Profile Addition To US FDA’s Regulatory Agenda
Agency is targeting January 2020 for release of controversial proposed rule to allow importation of certain types of prescription drugs from Canada; although most Rx drug-related proposed and final rules on the Fall 2019 regulatory agenda are making repeat appearances, a final rule on electronic distribution of prescribing information has fallen off the list.
FDA To Provide Expedited Approval Desktop Reference
Comprehensive guidance document is expected to describe FDASIA changes and clarify terms that have become confusing as more pathways emerge to speed drug approvals.
Clinical Trial Regs: FDA Seeks Advice On How To Make Them Better, Faster, Stronger
FDA is holding a two-day public hearing to get input on how to modernize its regulation of clinical trials; stakeholders cite need for innovative trial design, data sharing, guidance on use of biomarkers.