“It’s Alive! It’s Alive!”: Court Rejects FDA’s HCT/P Designation as Arbitrary and Capricious

The Edgar Winter Group’s 1972 instrumental track, “Frankenstein,” and Gene Wilder’s “It’s alive!” exclamation in the 1974 Young Frankenstein movie came to mind when we read a recent court decision that rejected a Food and Drug Administration decision classifying a human tissue-based wound care powder as a biological product….
By: Arnall Golden Gregory LLP