Monday, August 4, 2014
FDA believes the global pharmaceutical
industry needs to modernize the way it makes drugs and active pharmaceutical ingredients.
The agency plans to prod, cajole, and if necessary whack companies into
changing the way they manufacture products, as well as their cultural
assumptions about quality.
investment in manufacturing technology and government investment in regulatory
science to support improved manufacturing could reduce quality-related blowups
that have derailed and delayed launches of new products, Janet Woodcock told