2024-24828. Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List  

  • Bulk drug substance Uses evaluated
    AOD-9604 (free base) *Obesity.
    AOD-9604 Acetate
    CJC-1295 (free base) Growth hormone deficiency.
    CJC-1295 Acetate
    CJC-1295 DAC (free base)
    CJC-1295 DAC Acetate
    CJC-1295 DAC Trifluoroacetate
    Thymosin alpha-1(free base) Hepatitis B.
    Thymosin alpha-1 Acetate Hepatitis C.
    Human immunodeficiency virus (HIV).
    Coronavirus disease 2019 (COVID-19).
    Depressed response to vaccinations; adjuvant to flu vaccines.
    Malignant melanoma.
    Hepatocellular carcinoma (HCC).
    Non-small cell lung cancer (NSCLC).
    Sepsis.
    Infections after hematopoietic stem cell transplantation (HSCT).
    Chronic obstructive pulmonary disease (COPD).
    Myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS).

Document Information

Published:
10/25/2024
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice; establishment of a public docket; request for comments.
Document Number:
2024-24828
Dates:
The meeting will be held on December 4, 2024, from 8 a.m. to 3 p.m. Eastern Time.
Pages:
85219-85221 (3 pages)
Docket Numbers:
Docket No. FDA-2024-N-4777
PDF File:
2024-24828.pdf