Tag:
FDA inspections
Latest Headlines
Latest Headlines
FDA nails Novo for missing 850 samples over 2 years
While most of the discussion of stepped-up inspections by the FDA of foreign manufacturing plants is about the need to keep track of China, it does not mean the industry's biggest players will escape tough oversight. The FDA has sent a scathing warning letter to Novo Nordisk about a plant in Denmark.
Ramp up of FDA's foreign inspections hits snag
The FDA's plan to level the plant inspection playing field by visiting foreign plants at least as often as it does U.S. facilities may not get off the ground in October as planned. Why? Because Congress hasn't gotten around to passing certain legislation needed to trigger it.
Track and trace details need to be worked out in FDA reauthorization
The House and Senate must reconcile over the level of supply-chain tracking that will be required of the industry to protect against counterfeit medications.
FDA builds program for outsourcing foreign plant inspections
The FDA likes the look of a program to outsource inspections, but it's caught in one of those pressure sandwiches between competing congressional concerns.
