Zdrowie i gospodarka · 02/06/1999

FDA Releases Draft Guidance for Nasal Spray and Inhalation Solution Drug Products

The Food and Drug Administration (FDA) has made available a draft guidance document outlining the required chemistry, manufacturing, and controls (CMC) documentation for new drug applications (NDA's) and abbreviated new drug applications (ANDA's) for nasal spray and inhalation solution, suspension, and spray drug products.