FDA
The new article addresses the aspects related to the content of a monitoring plan, as well as the follow-up procedures and the way they should be documented. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
Europe
The new article describes in detail special projects the authority intends to implement in order to introduce specific needs associated with the products based on innovative technologies. Table of Contents The Medicines and Healthcare Products Regulatory Agency...
FDA
The new article highlights the aspects related to the way changes to a change control plan could be introduced, and also provides additional explanations regarding the way the proposed modifications should be described in the respective section of a plan. Table of...
FDA
The new article addresses the aspects related to special factors to be considered when developing a monitoring plan, the way centralized monitoring should be implemented, and also emphasizes the importance of maintaining blinding to mitigate risks associated with...
Europe
The new article addresses the matters related to the regulatory status of the products based on artificial intelligence technology, regulated as medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), a UK authority in the...
FDA
The new article addresses the aspects related to the way the need in a new marketing submission should be determined and to the implementation of modifications. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
