Newsletter - July 11, 2024
How to Deal with Off-Label Information: New FDA Guidance With Old Info
Ten years ago, the FDA published a guidance document about its opinion on what manufacturers should do when they become aware of independently generated off-label information about their approved products. This week, the FDA published an update to that guidance with similar info but with more...Read More
How to Use Real World Data to Generate New Safety Information for Drugs
Post-market pharmacovigilance could be improved to collect robust data from the use of products to generate data acceptable to regulatory agencies for new claims for the safety of the products. A new ICH guidance describes various parameters to plan for which would create such robust data. Read More
How to Deal with Off-Label Information: New FDA Guidance With Old Info
Ten years ago, the FDA published a guidance document about its opinion on what manufacturers should do when they become aware of independently generated off-label information about their approved products. This week, the FDA published an update to that guidance with similar info but with more...Read More
How to Use Real World Data to Generate New Safety Information for Drugs
Post-market pharmacovigilance could be improved to collect robust data from the use of products to generate data acceptable to regulatory agencies for new claims for the safety of the products. A new ICH guidance describes various parameters to plan for which would create such robust data. Read More
