Discussion of whether universal testing of blood donations for ZIKV is an appropriate strategy considering the decline of the epidemic
Overview of the research programs in the Laboratory of Biochemistry and Vascular Biology in the Division of Blood Components and Devices, Office of Blood Research and Review, CBER, FDA
Blood donation policies regarding men who have sex with men (MSM)
Read MoreSelinexor tablets, submitted by Karyopharm Therapeutics, Inc., for use, in combination with dexamethasone, in the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody
Read MoreEsketamine nasal spray, submitted by Janssen Pharmaceuticals, Inc., for the treatment of treatment-resistant depression.
Read MorePRE-PEN PLUS, a proposed skin test kit for penicillin allergy by AllerQuest
Read MoreZynquista (sotagliflozin) oral tablet, sponsored by Sanofi-Aventis U.S., LLC (Sanofi), for the proposed indication of use as adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. Zynquista is being developed in partnership with Lexicon Pharmaceuticals, Inc.
Read MoreEVENITY (romosozumab) injection, submitted by Amgen, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant of other available osteoporosis therapy
Read MoreCardiovascular Safety of Takeda’s Gout Drug, Uloric (febuxostat)
Read MoreImmediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc.
Read MoreCardiovascular risk assessment of drugs for the treatment of type 2 diabetes mellitus and related FDA guidance
Read MoreCT-P10, a proposed biosimilar to Rituxan (rituximab) by Celltrion, Inc.
Read MoreRecommendations on the selection of strains to be included in an influenza virus vaccine for the 2019 Southern Hemisphere influenza season
Read MorePediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Updates on general safety topics.
Read MoreFollow-up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements.
Discussion of six bulk drug substances nominated for inclusion on the 503A Bulks List.: alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin
Read MoreAmikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen
Read MoreResults from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS)
Read MoreTafenoquine tablet, 100 milligram (mg), sponsored by 60 Degrees Pharmaceuticals, for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing
Read MoreTafenoquine tablet, 150 milligram, sponsored by GlaxoSmithKline, for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax malaria
Read MoreOmadacycline tablets and injection, sponsored by Paratek Pharmaceuticals, Inc., for the proposed indications for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections
Read MoreSubpart A Subcommittee and Subcommittee on Harmonization recommendations for the revised Common Rule and related discussions
Read MoreSupplemental biologics license application or mepolizumab for injection, submitted by GlaxoSmithKline for add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts
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