The new article describes in detail the aspects related to the content of deficiency letters, their review, as well as the way the authority expects the industry to respond to such letters. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
The article provides an overview of the regulatory requirements related to handling post-approval studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...
The new article highlights the most important aspects related to the application of the least burdensome approach for deficiencies arising from the issues identified by the authority when reviewing the application for marketing approval. Table of Contents The Food...
The article provides an overview of the policy suggested for deficiencies in medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
The new article highlights the key points related to clinical outcome studies that are not using concurrent (or historical) controls. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...