Food Safety & Nutrition
Documents
Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities—March 2026
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CH Biotech R&D Co., Ltd. Notice of Filing Pesticide Petition requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for the biochemical pesticide melatonin
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Letter from Tricia Spencer to FDA HFP
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Citizen Petition from Windels Marx Lane & Mittendorf, LLP
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Acknowledgement Letter from FDA DMB to Windels Marx Lane & Mittendorf, LLP
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Reference 1 - Draft Guidance on Dabrafenib Mesylate
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Reference 2 - Criteria for waiver of evidence of in vivo bioavailability or bioequivalence
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Reference 3 - Prescribing Information for TAFINLAR
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Reference 4 - Petition to request a change from a listed drug
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Reference 5 - Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidance
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Reference 6 - Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage Forms
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Reference 7 - Improving the Dissolution Rate of the Anticancer Drug Dabrafenib
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