The definition of silk is something smooth like or made of the very soft and fine threads spun by silkworms. An example of silk is smooth and creamy chocolate truffles; silk truffles.
Biologic response modifiers, also known as biologics, are medications that were designed to prevent or reduce the inflammation that damages joints. Biologics target molecules on cells of the immune system, joint, and the products that are secreted in the joint, all of which can cause inflammation and joint destruction.
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). 1  The BLA is regulated under 21 CFR 600 â 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA.