📄FDA's Draft Guidance for Electronic Submission of Medical Device Q-Submissions
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Q-Submissions." FDA is issuing this draft guidance to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-subs) to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), to the current resources and associated content developed and made publicly available to support Pre-Sub electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.
Learn More📊FDA Seeks Comments on Electronic Study Data Submission Standards
The Food and Drug Administration (FDA or Agency) is exploring Clinical Data Interchange Standards Consortium (CDISC) Dataset- JavaScript Object Notation (Dataset-JSON) version 1.1 as a new exchange standard, with the long-term potential to replace Statistical Analysis System (SAS) version 5 XPORT Transport Format (XPT), for submission of electronic study data to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). FDA is requesting comments on whether to accept Dataset-JSON to exchange electronic study data as part of regulatory applications in the future. In particular, FDA is requesting feedback on the risks and benefits of industry adopting Dataset-JSON as a new exchange standard for submitting electronic study data to FDA and any integration challenges with existing tools and systems.
Learn More🌱Revised Pesticide Registration Procedures and Business Implications
The Environmental Protection Agency (EPA or Agency) is announcing the availability of Pesticide Registration Notice (PR Notice) 2025-1, entitled "Revised Procedures for Citing Data to Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35)." PR Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This PR Notice supersedes PR Notice 98-5, entitled "New forms for the Certification with Respect to Citation of Data" dated June 12, 1998. The revised procedures eliminate the requirement to submit two paper versions of the completed data matrix form and establishes electronic online submissions. EPA anticipates that these changes will reduce burden for the registrants and the Agency.
Learn More✈️FAA Updates Aircraft Registration and Submission Procedures 2025
The FAA is updating certain procedural regulations relating to civil aircraft registration and recordation to provide administrative relief from the requirements for submitting original documents and to sunset the FAA's practice of stamping documents. Amending these regulations will reduce administrative burdens and enable the FAA to better utilize the capabilities of the Civil Aviation Registry Electronic Services (CARES) system for civil aircraft registration and recordation.
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