New clinical data quality course for high-consequence pathogens | Emergency diagnostics news

Information for industry February 26, 2019: Draft guidance - Quality Considerations for Continuous Manufacturing(PDF, 197 KB), to clarify the FDA’s current thinking regarding innovative CM approaches and can help resolve potential issues some companies have as they consider implementation. Comment by May 28, 2019. Also see: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing (February 26, 2019) FDA is reminding stakeholders that February 21, 2019 is the effective date for compliance with the final rule on Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices (Federal Register notice, February 21, 2018). The rule updates the standards for accepting clinical data from clinical investigations conducted inside and outside the United States to protect human participants, and to help ensure the quality and integrity of data obtained through such investigations. On March 19, 2019, FDA will host a webinar for stakeholders who want to learn more about the implementation of this final rule. Also see: Acceptance of Data from Clinical Investigations for Medical Devices FDA is reopening the comment period for the proposed rule entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” that appeared in the Federal Register of November 15, 2018.  FDA is taking this action due to technical difficulties at the Federal eRulemaking portal. Comments on the proposed rule may be submitted at  https://www.regulations.gov (Docket No. FDA-2018-N-2727) and are now due by March 7, 2019. More: MCM-Related Guidance by Date