Deze vertaling wordt voorbereid. Voorlopig tonen we de oorspronkelijke Engelse versie.
Bedrijven · 21-8-20021 min lezen
Draft Guidance for Industry on Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Availability
Lokale automatische vertaling · Oorspronkelijke brontaal
Samenvatting
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation." This guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); human pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs).
Oorspronkelijke brontaal: Federal Register — Food and Drug AdministrationOrigineel bericht openen →