Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Topics	Advisory Committee	Date	Details
Drug development for testosterone replacement therapy in male adolescents for conditions associated with a deficiency or absence of endogenous testosterone resulting from structural or genetic etiologies (“classic hypogonadism”)	Pediatric	April 8	Meeting notice (Also see "Pediatric Testosterone Therapy: Sponsors Wary Of Trials Despite PREA" - Pink Sheet, 4 Apr, 2019.)
Pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis	Antimicrobial Drugs	April 25	Meeting notice
Safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug	Antimicrobial Drugs	April 26	Meeting notice
Approaches to evaluate the effect of renal impairment on drug exposure; best practice considerations for translating pharmacokinetic information into dose individualization instructions	Pharmaceutical Science and Clinical Pharmacology	May 7	Meeting notice
Chiesi USA's mannitol inhalation powder for management of cystic fibrosis to improve pulmonary function in patients ages 18 years and older in conjunction with standard therapies	Pulmonary-Allergy Drugs	May 8	Meeting notice
Daiichi Sankyo's pexidartinib for adults with symptomatic tenosynovial giant cell tumor	Oncologic Drugs	May 14	Meeting notice
Daiichi Sankyo's quizartinib for adults with relapsed/refractory acute myeloid leukemia, which is FLT3-ITD positive as detected by an FDA-approved test	Oncologic Drugs	May 14	Meeting notice