FDA set for E2B IND Safety Reporting
The FDA has published a new draft guidance for comments, which will require sponsors to submit IND safety reports to the FAERS database in the ICH E2B format. The Agency highly encourages all sponsors to begin voluntary submissions as soon as the new process is available.
FDA Best Practices on Signal Management
The FDA is requesting comments on a draft document that describes the approach used at the Agency for ongoing postmarketing safety surveillance for drug and biological products.
FDA Guidance on Post-Marketing Studies
The FDA has published a new draft guidance document describing the process for the FDA to require Postmarketing Studies and Clinical Trials in order to address a safety concern. This is a revision of the 2011 guidance, which covers both studies that the FDA may request as postmarketing requirements (PMRs) or commitments (PMCs).
New EU GCP Guidelines for ATMPs
Further to the consultation started in August 2018, the European Commission has published the final Guideline on Good Clinical Practice (GCP) specific for Advanced Therapy Medicinal Products (ATMPs). The document covers aspects related to Safety Reporting, Long-Term Follow-Up, Risk Minimisation and the use of Patient Alert Cards.
Hot topics are taken from Safety Observer Lite 161, Nov 2019