Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
Understanding ICH M10 “Bioanalytical Method Validation and Study Sample Analysis”
The final version of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” was adopted on May 24, 2022. This is the harmonized guideline which has been ratified by participating...
The Importance of the eCTD Structure for FDA Approval
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...