Biznes · 25.07.20181 min czytania
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments; Draft Guidance for Industry; Availability
Automatyczne tłumaczenie lokalne · Oryginalny język źródła
Streszczenie
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments." This draft guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids and/or soft foods as vehicles for drug administration in investigational new drug applications (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), as applicable, and in supplements to these applications.