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...
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...
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...
FDA
The new article describes in detail the way a risk-based approach should be applied with respect to clinical trials involving human subjects, paying special attention to the initial risk assessment to be carried out by the party responsible for a clinical...
FDA
The new article highlights the aspects related to the applicable policy and outlines the key points to be taken into consideration. Table of Contents The Food and Drug Administration (FDA), the US regulating authority in the sphere of healthcare products, has...
