LS&HC Horizons 2022 - Flipbook - Page 65
10
United States
Buy American: Efforts to strengthen the U.S. industrial base
66
FDA formal dispute resolution and administrative
hearing procedures
67
More FDA inspections are coming soon
68
Real-World Evidence regulatory considerations in the
United States
69
Reclassification of certain drugs as devices and
combination products after Genus v. FDA
70
Combination products and Part 4 compliance
71