Agency
Food and Drug Administration
FDADockets
144
Documents mirrored
72
Comments
14,172
4,341 awaiting analysis
Rulemaking
Documents
What this agency has published, newest first.
- Variance Approval Letter to PrivateerOther
Posted Jun 10, 2026
- Variance Application from PrivateerOther
Posted Jun 10, 2026
- Acknowledgment Letter from FDA DMB to PrivateerOther
Posted Jun 10, 2026
- Variance Approval Letter to Maricopa County Community College DistrictOther
Posted Jun 10, 2026
- Other
- ComplaintOther
Posted Jun 10, 2026
- Variance Application from Maricopa County Community College DistrictOther
Posted Jun 10, 2026
- Medical Devices: Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device For the Relief of TinnitusRule
Posted Jun 10, 2026
- Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related InformationNotice
Posted Jun 10, 2026
- Response Letter from FDA CDER to HQ Pharma (Shanghai) Co., Ltd.Other
Posted Jun 9, 2026
- Reference 3 - Prescribing Information for TAFINLARSupporting & Related Material
Posted Jun 9, 2026
- Reference 1 - Draft Guidance on Dabrafenib MesylateSupporting & Related Material
Posted Jun 9, 2026
- Reference 4 - Petition to request a change from a listed drugSupporting & Related Material
Posted Jun 9, 2026
- Reference 5 - Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidanceSupporting & Related Material
Posted Jun 9, 2026
- Supporting & Related Material
- Acknowledgement Letter from FDA DMB to Evan H. CoutureOther
Posted Jun 9, 2026
- Supporting & Related Material
- Reference 9 - Population pharmacokinetics of dabrafenibSupporting & Related Material
Posted Jun 9, 2026
- Reference 10 - Dabrafenib in patients with melanomaSupporting & Related Material
Posted Jun 9, 2026
- Reference 2 - Criteria for waiver of evidence of in vivo bioavailability or bioequivalenceSupporting & Related Material
Posted Jun 9, 2026
- Reference 11 - Assessment of the drug interaction potentialSupporting & Related Material
Posted Jun 9, 2026
- Supporting & Related Material
- Reference 15 - Evaluation of the effect of dabrafenib and metabolites on QTc interval in patientsSupporting & Related Material
Posted Jun 9, 2026
- Reference 16 - Evaluating the Role of Solubility in Oral Absorption ofSupporting & Related Material
Posted Jun 9, 2026
- Reference 17 - In Silico Modelling Approach for the Evaluation ofSupporting & Related Material
Posted Jun 9, 2026
- Reference 18 - Bioequivalence Studies for Generic Drug DevelopmentSupporting & Related Material
Posted Jun 9, 2026
- Reference 20 - Citizen Petitions and Petitions for Stay of Action Subject to Section 505q of the Federal Food Drug and Cosmetic ActSupporting & Related Material
Posted Jun 9, 2026
- Supporting & Related Material
- Reference 21 - Draft Guidance on RifaximinSupporting & Related Material
Posted Jun 9, 2026
- Other
- Reference 12 - Clinical Pharmacology Review of NDA 202806Supporting & Related Material
Posted Jun 9, 2026
- Reference 14 - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral DosageSupporting & Related Material
Posted Jun 9, 2026
- Reference 22 - Bioequivalence safety and tolerability of imatinib tablets compared with capsulesSupporting & Related Material
Posted Jun 9, 2026
- Reference 6 - Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage FormsSupporting & Related Material
Posted Jun 9, 2026
- Citizen Petition from Windels Marx Lane & Mittendorf, LLPOther
Posted Jun 9, 2026
- ComplaintOther
Posted Jun 9, 2026
- ComplaintOther
Posted Jun 9, 2026
- ComplaintOther
Posted Jun 9, 2026
- ComplaintOther
Posted Jun 9, 2026
- ComplaintOther
Posted Jun 9, 2026
- Acknowledgment Letter from FDA DMB to Evan H. CoutureOther
Posted Jun 9, 2026
- Interim ResponseOther
Posted Jun 9, 2026
- ComplaintOther
Posted Jun 9, 2026
- ComplaintOther
Posted Jun 9, 2026
- Citizen Petition from Evan H. CoutureOther
Posted Jun 9, 2026
- Citizen Petition from Evan H. CoutureOther
Posted Jun 9, 2026
- Citizen Petition from Evan H. CoutureOther
Posted Jun 4, 2026
- Acknowledgement Letter from FDA DMB to Evan H. CoutureOther
Posted Jun 4, 2026
- Citizen Petition from Pharmaceutical Safety Oversight CouncilOther
Posted Jun 3, 2026
- Citizen Petition from Animal Defenders InternationalOther
Posted Jun 2, 2026