News dal mondo
Removing Gaps in Data Integrity
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards....[PharmTech]
MHRA Updates Guidance on ‘No-Deal’ Brexit Scenario
The UK’s Medicines and Healthcare Products Regulator Agency updated its guidance for how medicines will be regulated in the event of a “no-deal”...
FDA Offers More Time to Join Quality Metrics Feedback Program
The FDA has reopened the submission period for its quality metrics feedback program, giving potential participants more time to sign up.
The CDMO Evolution
The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise...[PharmTech]
Implications of the SPC Waiver
Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the...