Zynquista (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 MoreJAN 16 BRUDAC
EVENITY (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 MoreJAN 11 AAC-DSRM
Cardiovascular Safety of Takeda’s Gout Drug, Uloric (febuxostat)
Read MoreOCT 14 AADPAC-DSRM
Immediate-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 MoreOCT 24-25 EMDAC
Cardiovascular risk assessment of drugs for the treatment of type 2 diabetes mellitus and related FDA guidance
Read MoreOCT 10 ODAC
CT-P10, a proposed biosimilar to Rituxan (rituximab) by Celltrion, Inc.
Read MoreOCT 3 VRBPAC
Recommendations on the selection of strains to be included in an influenza virus vaccine for the 2019 Southern Hemisphere influenza season
Read MoreSEP 20 PEDAC
Pediatric-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 MoreSEP 12 PCAC
Follow-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 MoreAUG 7 AMDAC
Amikacin 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 MoreAUG 3 AADPAC-DSRM
Results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS)
Read MoreJUL 26 AMDAC
Tafenoquine 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 MoreJUL 12 AMDAC
Tafenoquine tablet, 150 milligram, sponsored by GlaxoSmithKline, for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax malaria
Read MoreAUG 8 AMDAC
Omadacycline 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 MoreJUL 10-11 SACHRP
Subpart A Subcommittee and Subcommittee on Harmonization recommendations for the revised Common Rule and related discussions
Read MoreJUL 25 PADAC
Supplemental 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
Read MoreJUN 26 AADPAC-DSRM
Remoxy ER (oxycodone extended-release capsules), submitted by Pain Therapeutics
Read MoreJUN 22 BPAC
Presentations on CBER Research Programs
Read MoreJUL 18-19 BPAC
Bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. Potential reclassification of nucleic acid and serology-based point-of-care and laboratory-based in vitro diagnostic devices indicated for use as aids in the diagnosis of human immunodeficiency virus (HIV) infection.
Read MoreJUN 20 ODAC
Review of proposed molecular targets for pediatric drug development that may be required under the Pediatric Research Equity Act
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