Newsletter - September 7, 2017
The Practical Implications of FDA and EMA Sharing Confidential GMP Information
FDA and EMA signed a mutual confidentiality arrangement this month which commits both agencies to share all information about manufacturing operations located in either region including trade secret and non-public information. The agreement will become effective on 1 Nov 2017 and will be in transition phase till July 2019 giving both agencies time to work out any issues due to the arrangement. Read More
FDA Explains What is Real World Evidence and How It Can Be Used
Real World Evidence (RWE) and Real World Data (RWD) are very important but distinct aspects of the clinical use information available for a drug. The 21st Century Cures Act mandates FDA to use RWE in support of the approval of a product and FDA’s opinion about the utility of such data in support of market approval is evolving rapidly. Read More
The Practical Implications of FDA and EMA Sharing Confidential GMP Information
FDA and EMA signed a mutual confidentiality arrangement this month which commits both agencies to share all information about manufacturing operations located in either region including trade secret and non-public information. The agreement will become effective on 1 Nov 2017 and will be in transition phase till July 2019 giving both agencies time to work out any issues due to the arrangement. Read More
FDA Explains What is Real World Evidence and How It Can Be Used
Real World Evidence (RWE) and Real World Data (RWD) are very important but distinct aspects of the clinical use information available for a drug. The 21st Century Cures Act mandates FDA to use RWE in support of the approval of a product and FDA’s opinion about the utility of such data in support of market approval is evolving rapidly. Read More
