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
Read MoreMAY 17 VRBPAC
1) Approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant
2) Overview of the research program in the Laboratory of Respiratory Viral Diseases (LRVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA
Read MoreMAY 1 AMDAC
Tecovirimat, by SIGA Technologies Inc., for the treatment of smallpox
Read MoreAPR 23 SBFDA
Hear about the CBER Program Review Subcommittee report; Hear about FDA’s Patient Affairs Initiative; Obtain advice to leverage existing tools and authorities, and work with stakeholders, to better address the complex scientific, public health, and technology challenges FDA faces today
Read MoreAPR 24-25 AAC DSRM
sNDA for CELEBREX (celecoxib), by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial
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