Newsletter - December 13, 2018
FDA Tries to Regulate LDTs.. Again!
It is no secret that FDA would like to regulate LDTs like other in vitro diagnostic (IVD) tests. FDA’s last attempt to do so in 2016 was withdrawn due to uncertain political conditions. Since then little has changed in the LDT space in terms of their use by patients, the number of providers, and it would seem...Read More
FDA Guidance on Data Integrity: A Must Read for All GMP Facilities
Data quality and integrity issues are the most common reasons for 483s and Warning Letters. Many of these arise from misunderstanding FDA’s expectations from common issues related to data and documentation generation, correction, and storage...Read More
FDA Tries to Regulate LDTs.. Again!
It is no secret that FDA would like to regulate LDTs like other in vitro diagnostic (IVD) tests. FDA’s last attempt to do so in 2016 was withdrawn due to uncertain political conditions. Since then little has changed in the LDT space in terms of their use by patients, the number of providers, and it would seem...Read More
FDA Guidance on Data Integrity: A Must Read for All GMP Facilities
Data quality and integrity issues are the most common reasons for 483s and Warning Letters. Many of these arise from misunderstanding FDA’s expectations from common issues related to data and documentation generation, correction, and storage...Read More
