FDA Publishes Draft Quality Risk Management Guidance
The draft ICH Q9(R1) document details the importance of quality risk management principles.
FDA announced on June 15, 2022 that it has published the International Council for Harmonisation’s (ICH) Q9(R1) Quality Risk Management draft guidance document. The draft version details the general quality risk management (QRM) process including risk assessment, risk control, risk communication, and risk review. It also discusses methodology for risk management and risk-based decision making.
The integration of QRM into the industry and regulatory operations is also discussed. The document includes two annexes. Annex I provides information on QRM methods and tools such as failure mode effects analysis, fault tree analysis, hazard analysis and critical control points, and more. Annex II breaks down QRM as parts of integrated quality management.
“In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry, and it is evident that quality risk management is a valuable component of an effective quality system,” the agency stated on its website.
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
