Recent And Upcoming FDA Advisory Committee Meetings

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

Topic	Advisory Committee	Date	Details
Discussion of six drug substances nominated for inclusion on the section 503A Bulk List eligible for compounding: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate and artemisinin. Also, discussion of oral solid modified-release drug products that employ coated systems, nominated for the "Difficult to Compound" list.	Pharmacy Compounding	May 8	Meeting notice
Recommendations on the agency’s Innovation Funds work plan as prescribed in Sec.1002 of the 21st Century Cures Act	Science Board	May 9 (meeting via audio webcast)	Meeting notice
NX Development Corp.’s 5-aminolevulinic acid hydrochloride powder (for oral solution) for use as an imaging agent to facilitate the real-time detection and visualization of malignant tissue during glioma surgery	Medical Imaging Drugs	May 10	Meeting notice
Considerations for evaluation of respiratory syncytial virus vaccine candidates in seronegative infants	Vaccines and Related Biological Products	May 17	Meeting notice
Puma Biotechnology’s neratinib maleate for single-agent, extended adjuvant treatment of adults with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy	Oncologic Drugs	May 24 (morning)	Meeting notice
Emmaus Medical’s L-glutamine powder (oral solution) for the treatment of sickle cell disease	Oncologic Drugs	May 24 (afternoon)	Meeting notice
Hospira’s (Pfizer) proposed biosimilar to Amgen Inc.’s Epogen/Procrit (epoetin alfa) for all of the indications on the reference biologic’s labeling	Oncologic Drugs	May 25	Meeting notice