Dockets

Requests that the FDA review whether the two primary generic bicalutamide tablet suppliers can assure the safety, efficacy, and quality of bicalutamide tablets for the intended prostate cancer patient population.

Requests that the FDA declare that Cyproheptadine Hydrochloride Orally Disintegrating Tablets, 2 mg, 3 mg, 4 mg and 6 mg is suitable for submission as an ANDA.

Requests that the Food and Drug Administration issue a written determination regarding the regulatory status of fluoride compounds distributed for community water fluoridation

Requests that the FDA require the manufacturer and any sponsors studying the Vena MicroAngioscope System (K251767 and K253842) (Vena MicroAngioscope) for neurovascular use, particularly in neurointerventional procedures including acute ischemic stroke thrombectomy, to apply for an Investigational Device Exemption (IDE)

Requests that the FDA evaluate the stability and safety at labeled storage conditions of Store at 20C to 25C (68F to 77F) (See USP Controlled Room Temperature) of Kesin Pharma's (Kesin) repackaged Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL unit-dose cups (NDC 81033-021-54)

Requests that the FDA: 1. Conduct or expedite the scientific and medical evaluation of psilocybin and MDMA under the eight factors in 21 U.S.C. S 811(c) and provide a scheduling recommendation to the Drug Enforcement Administration

Requests that the FDA: 1. Revise or issue new guidance (and initiate rulemaking as necessary) under 21 CFR Part 1271, Subpart C, to exempt or substantially streamline donor eligibility requirements (screening, physical examination, infectious disease testing, and eligibility determination) for directed/known reproductive donations

Requests that the FDA 1. Revise the guidance document(s) and, as necessary, associated regulations under 21 CFR Part 1271 for determining donor eligibility of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), including reproductive tissues such as semen, to remove or substantially narrow geographic residency and travel deferrals related to variant Creutzfeldt-Jakob Disease

Docket for Submission of FMCSA Petitions for Rulemaking.

21 awaiting analysis

Burlington Northern Santa Fe Corporation - Waiver Petition

Shell Docket for the Federal Railroad Administration (FRA)

6 awaiting analysis

The Association of American Railroads (AAR)