📄FDA Announces M11 Technical Specification for Clinical Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of the revised draft technical specification entitled "M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)" and a supplemental document entitled "M11 Template." The revised draft technical specification and template were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information. The template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. These ICH documents create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This revised draft technical specification and updated template revise and replace the draft versions of the same titles issued in December 2022.
Learn More🏭Proposed Rule for Holtec HI-STORM UMAX Storage Casks Amendment
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International HI-STORM UMAX Canister Storage System listing within the "List of approved spent fuel storage casks" to include Revision 1 to Amendment Nos. 0 through 2 to Certificate of Compliance (CoC) No. 1040. Revision 1 to Amendment Nos. 0 through 2 updates the CoC appendix A technical specifications for radiation protection and the associated bases information to clearly articulate the basis for the dose rate limits for the closure lids, modify the dose rate limit values and the description of the location of the dose rate measurements, and make other editorial changes.
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