The FDA has long considered that even minor changes in the production of biological drugs--including exactly the same isolation and purification procedures applied at significantly larger scale than previously--yield a distinct and new drug that must undergo an independent demonstration of safety and efficacy.

FORBES: Commentary

Working either through the charter movement or the home schooling movement would enable a tablet textbook project to start small, yield immediate returns to participants, and scale easily, while largely ignoring the interests of incumbent institutions.

FORBES: Don't Expect Apple's Digital Textbook Innovation To Come From The Top Down