UMB Data Catalog

A project of the Health Sciences and Human Services Library

Filter by

of 1 Next >
Results Found: 1
  • UMB Dataset

    Substances nominated for inclusion on the 503B Bulks List: Alpha Lipoic Acid

    Alternate Title(s)
    Alpha Lipoic Acid: Summary Report
    Authors
    SeJeong Yoon
    Stephanie L. Gianturco
    Laura L. Pavlech
    Kathena D. Storm
    2 more author(s)...
    Description

    The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the...

    Subject
    Drug Compounding
    Legislation, Drug
    Thioctic Acid
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access