Supplements to New Drug Applications, Abbreviated New Drug Applications, or Abbreviated Antibotic Applications for Nonsterile Drug Products; Draft Guideline; Notice

Streszczenie

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Draft Guideline on Supplements to NDA's, ANDA's, or AADA's for Nonsterile Drug Products.'' This draft guideline is intended to help distinguish between manufacturing changes that require prior approval through a supplement to an approved new drug application (NDA), abbreviated new drug application (ANDA), or abbreviated antibiotic application (AADA), manufacturing changes that require a supplement but that may be made prior to approval of the supplement, and those manufacturing changes that need only to be described in an annual report. The draft guideline covers certain changes in the method of manufacture that involve equipment changes, reprocessing of drug products that fail to meet specifications, and changes made to the physical facility. The draft guideline also advises manufacturers of their statutory obligation to comply with the current good manufacturing practice regulations regardless of whether or not they submit a supplement to an application.