The Quality Lowdown: ICH Q9, FDA QMM, THC Impurities And Recertified MAPPs
Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.
You may also be interested in...
US FDA Makes Case For Quality Management Maturity Ratings
High ratings could strengthen company financial performance, agency suggests. But stakeholders would need to understand the difference between site QMM and product quality for the incentives to work properly. More details to follow in upcoming workshop.
ICH Q9 Revision Delayed By Three Months Due To COVID; Focus Spans Risk Assessments, Shortages
Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.
US CBD Supplement Market Anxious For Lawful Use Proposal, And FDA Offers Cannabis Drug Research Guidance
Adding more cannabis-containing drugs to the three already approved in the US relies on research, but hundreds of supplements and other FDA-regulated non-drug products containing CBDs already are available under enforcement discretion by the agency.