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As FDA states in their guidance document on the Q-Submission program, Early interaction with FDA on planned non-clinical and clinical studies and careful consideration of FDAs feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices. While this is not meant to be a general pre-review of your submission, it is there to help you get answers to questions directly from FDAwhich will contribute to a smooth submission and, hopefully, approval
Community research peptide protocols use 1.5 mg/week total roughly 60% of the FDA starting dose and 10% of the maximum
Certificates of analysis should document: Purity percentages with detection method specifications Mass spectrometry data confirming molecular weight Sterility testing results using USP methods Endotoxin levels measured by LAL assay Synthesis and Manufacturing Standards Research-grade peptides should come from facilities following GMP protocols
A study using kinase dead Ikk knock-in [ Ikk KA/KA ] mice, mimicking similar phenotypic characteristics as seen in APECED patients, demonstrated that autoreactive T-cells permit fungal infection
