ComplianceLogix 10/25/23 ComplianceLogix 10/25/23

FDA Issues Draft Guidance for Remote Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities

ComplianceLogix 9/16/22 ComplianceLogix 9/16/22

Draft FDA Guidance for Computer Software Assurance for Production and Quality System Software

The FDA issued a draft Guidance for Computer Software Assurance for Production and Quality System Software.

ComplianceLogix 8/22/22 ComplianceLogix 8/22/22

FDA Responses to Good Clinical Practice Inquiries

FDA answers GCP questions

ComplianceLogix 4/8/22 ComplianceLogix 4/8/22

ICH E8(R1) General Considerations for Clinical Studies

ComplianceLogix 8/31/21 ComplianceLogix 8/31/21

Conduct of Clinical Trials During the COVID-19 Public Health Emergency

ComplianceLogix 4/21/21 ComplianceLogix 4/21/21

FDA Issues Guidance on Remote Inspections

FDA Remote Inspections

Brett Vengroff 8/26/20 Brett Vengroff 8/26/20

GCP Serious Breaches Update

ComplianceLogix 6/3/20 ComplianceLogix 6/3/20

FDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials

Brett Vengroff 5/12/20 Brett Vengroff 5/12/20

Best Practices for Remote Audits

The coronavirus (COVID-19) pandemic has forced biotechnology, pharmaceutical, and medical device companies to suspend normal operations and transition to new and innovative ways of doing business. With current restrictions on international and domestic travel, traditional on-site audits are not possible, exposing organizations to increased compliance risk. In some cases, remote audits may provide a viable alternative to ensure continued compliance and oversight. This article will summarize best practices for selecting and conducting remote internal and external audits.

ComplianceLogix 4/16/20 ComplianceLogix 4/16/20

FDA Guidance on Conduct of Clinical Trials during COVID-19

FDA guidance on the conduct of clinical trials of medical products during the coronavirus (COVID-19) Public Health Emergency

ComplianceLogix 6/23/19 ComplianceLogix 6/23/19

FDA Guidance on Providing Regulatory Submissions in Electronic and Non-Electronic Format

ComplianceLogix 10/12/18 ComplianceLogix 10/12/18

FDA issues guidance for Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations

ComplianceLogix 5/29/18 ComplianceLogix 5/29/18

Final FDA Guidance on Bioanalytical Method Validation

FDA Final Guidance on Bioanalytical Method Validation

ComplianceLogix 2/20/18 ComplianceLogix 2/20/18

FDA releases final rule on Acceptance of Data from Clinical Investigations for Medical Devices

Brett Vengroff 7/24/17 Brett Vengroff 7/24/17

FDA Guidance for IRB Waiver or Alteration of Informed Consent

The United States Food and Drug Administration (FDA) issued a guidance for immediate implementation to Sponsors, Investigators, and Institutional Review Boards for the waiver of alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects.