Search Results for keywords:"regulatory submissions"

The U.S. Department of Energy (DOE) is seeking input from stakeholders and the public on how to prioritize its energy conservation rulemaking activities. This effort is part of the DOE's rulemaking methodology, known as the Process Rule, and aims to gather feedback on which rules should be prioritized and how quickly they should be addressed. Stakeholders are invited to review the DOE's active and long-term appliance rules and comment on their timing and categorization by March 11, 2021. Comments can be submitted via the Federal eRulemaking Portal or by email, following the instructions provided in the notice.

The Food and Drug Administration (FDA) has released a final guidance document titled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." This guidance aims to help manufacturers of tobacco products ensure that their testing methods for ingredients, constituents, and additives are consistent, reliable, and suitable for regulatory submissions. The document outlines best practices in analytical testing, including validation and verification of methods, which are crucial for regulatory compliance concerning new and modified risk tobacco products. The guidance also incorporates feedback from a draft issued in December 2021 and emphasizes the use of standard analytical methods.

The Food and Drug Administration (FDA) has announced a draft guidance titled "IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations." This draft is aimed at helping sponsors who are developing personalized antisense oligonucleotide (ASO) drugs for severe or life-threatening genetic diseases, especially for those patients without other treatment options. It provides instructions on interacting with the FDA, making regulatory submissions, and ensuring ethical considerations like informed consent. The FDA encourages feedback on this draft to aid in the creation of the final guidance, which will assist in the swift start of drug investigations.

The Food and Drug Administration (FDA) is releasing draft guidance on studying sex differences in the clinical evaluation of medical products. This guidance aims to improve the representation of females in clinical trials and provide recommendations for analyzing sex-specific data. It highlights the importance of understanding different responses to treatments based on sex to improve safety and effectiveness. The public is encouraged to submit comments on this draft guidance by April 7, 2025.