Documents

Federal rules and notices from the public comment record, analyzed continuously.

• Reference 2 - Criteria for waiver of evidence of in vivo bioavailability or bioequivalenceFDASupporting & Related Material
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• Reference 3 - Prescribing Information for TAFINLARFDASupporting & Related Material
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• Reference 4 - Petition to request a change from a listed drugFDASupporting & Related Material
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• Reference 5 - Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidanceFDASupporting & Related Material
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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 FormsFDASupporting & Related Material
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• Reference 7 - Improving the Dissolution Rate of the Anticancer Drug DabrafenibFDASupporting & Related Material
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• Reference 8 - A Theoretical Basis for a Biopharmaceutic Drug ClassificationFDASupporting & Related Material
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• Reference 9 - Population pharmacokinetics of dabrafenibFDASupporting & Related Material
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• Reference 10 - Dabrafenib in patients with melanomaFDASupporting & Related Material
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• Reference 11 - Assessment of the drug interaction potentialFDASupporting & Related Material
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• Reference 12 - Clinical Pharmacology Review of NDA 202806FDASupporting & Related Material
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• Reference 13 - M9 Biopharmaceutics Classification System-Based BiowaiversFDASupporting & Related Material
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• Reference 14 - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral DosageFDASupporting & Related Material
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• Reference 15 - Evaluation of the effect of dabrafenib and metabolites on QTc interval in patientsFDASupporting & Related Material
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• Reference 16 - Evaluating the Role of Solubility in Oral Absorption ofFDASupporting & Related Material
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• Reference 17 - In Silico Modelling Approach for the Evaluation ofFDASupporting & Related Material
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• Reference 18 - Bioequivalence Studies for Generic Drug DevelopmentFDASupporting & Related Material
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• Reference 19 - Improving the Dissolution Rate of the Anticancer Drug DabrafenibFDASupporting & Related Material
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• Reference 20 - Citizen Petitions and Petitions for Stay of Action Subject to Section 505q of the Federal Food Drug and Cosmetic ActFDASupporting & Related Material
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• Reference 21 - Draft Guidance on RifaximinFDASupporting & Related Material
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• Reference 22 - Bioequivalence safety and tolerability of imatinib tablets compared with capsulesFDASupporting & Related Material
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• Citizen Petition from Evan H. CoutureFDAOther
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• Acknowledgement Letter from FDA DMB to Evan H. CoutureFDAOther
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• Citizen Petition from Evan H. CoutureFDAOther
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• Acknowledgment Letter from FDA DMB to Evan H. CoutureFDAOther
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• Variance Application from PrivateerFDAOther
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• Acknowledgment Letter from FDA DMB to PrivateerFDAOther
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• Variance Approval Letter to PrivateerFDAOther
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• Variance Application from Maricopa County Community College DistrictFDAOther
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• Acknowledgment Letter from FDA DMB to Maricopa County Community College DistrictFDAOther
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• Variance Approval Letter to Maricopa County Community College DistrictFDAOther
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• Medical Devices: Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device For the Relief of TinnitusFDARule
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• Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related InformationFDANotice
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