• Publication Date: 12/01/2018
  • Author(s):
    Breit, Jeffrey Das, Aditya R.
  • Organization(s):
    CADA Consulting, LLC Recipharm
  • Article Type: Technical Articles
  • Subjects: Product Development/Formulation, Testing, Validation, and Regulatory Compliance
Spray-dry manufacturing is amenable to a variety of compound chemistries and may be a useful tool for the development of inhalation drug products that pursue the US FDA’s 505(b)(2) submission pathway.

The 505(b)(2) New Drug Application (NDA) is one of the United States Food and Drug Administration (FDA) drug approval pathways and may represent an appealing regulatory strategy for groups seeking to use a precedented compound in a new inhalation delivery modality.

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