By specifically targeting the affected cells or tissues, the drug can be delivered directly to the site of action, increasing its effectiveness while minimizing side effects on healthy cells.
Fast track designation (FTD) is a process used by the U.S. Food and Drug Administration (FDA) tofacilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
The U.S. FDA offers Fast Track Designation and Breakthrough Therapy Designation to speed up the development and review of drugs for serious conditions lacking treatments. Yet, they differ in key aspects.
Protein palmitoylation is a post-translational modification that involves the addition of a 16-carbon saturated fatty acid, typically palmitate (C16:0), to cysteine residues within target proteins.
In the U.S. FDA context, "Requirement/Commitment Status" generally refers to a manufacturer's or sponsor's obligations for regulatory approval, post-approval studies, or marketing authorization conditions for drugs, devices, or regulated products.