Fdcommendations on the selection of strains to be included in an influenza virus vaccine for the 2019 Southern Hemisphere influenza season

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.

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

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