with combination products include regulatory demands, current Good Manufacturing Practice (cGMP
) requirements, and technical considerations.
Combination products are subject to specific FDA
regulations related to their constituent parts, meaning components must be addressed individually. Human factor and clinical study considerations also need to be taken into account for combination products.
Combination products must follow current GMP guidance, and as with regulatory demands, cGMP requirements apply to constituent parts.
Combination products require a special FDA marketing application. Following this guidance is key to a streamlined process.