Mark Durivage

Jun 5, 2023 | qualitymag.com | Mark Durivage

Most ISO standards and Food and Drug Administration (FDA) regulations for quality management systems (QMS) have requirements for competence, awareness, and training of employees and individuals under the organization’s control.

Apr 5, 2023 | clinicalleader.com | Mark Durivage |Craig Morgan |Stuart Redding |Kerry Leyden

FDA Seeks Comment On Considerations For Externally Controlled Trials For Drugs, Biologics   Guest Column | By Mark Durivage, Quality Systems Compliance LLC   On February 1, 2023, the FDA released a new guidance, "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products," for public comment. It provides recommendations to sponsors and investigators, addresses considerations for the design and analysis of such trials, and more.

Mar 23, 2023 | clinicalleader.com | Mark Durivage |Julie Ozier

You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences. Clinical Sites | Patient Centricity | Patient Recruitment (Monday) Clinical Trial Technology (Tuesday) Decentralized Trials | Trial Management (Wednesday) Outsourcing Models | Regulatory & Compliance (Thursday) (Friday)Learn more about our personalized newsletters here.

Mar 10, 2023 | clinicalleader.com | Mark Durivage |Bruce Palsulich |Gary Shorter |Pankaj Manon

New FDA Draft Guidance Addresses Data Considerations For Externally Controlled Trials   Guest Column | By Mark Durivage, Quality Systems Compliance LLC   The FDA recently released for public comment Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.

Mar 1, 2023 | lifescienceleader.com | Mark Durivage

By Mark Durivage, Quality Systems Compliance LLC On Dec. 15, 2022, the FDA released for public comment Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The proposed draft guidance document seeks to update the current guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection published in October 2014. The October 2014 FDA guidance will remain in effect until it is officially withdrawn.