The industry has been talking about, and slowly working toward, track-and-trace for many years. Now Pharma faces real deadlines that require action.
The holiday's are upon us and we realize many of our readers will be taking a break. We intend to join you. The next issue of FiercePharmaManufacturing will be Jan. 3, after the holidays.
It looks like a national track and trace system is going to be implemented in the U.S. sooner rather than later. Differences between what industry believes it is capable of handling and what regulators believe it must kept it out of the FDA reauthorization bill, but no one should think that put it into the deep freeze.
Every week there is some news, recall or event that reminds us that the give and take with the FDA over manufacturing often means poor GMPs give companies major headaches and take a lot of time and money to resolve. The examples you will find in our 2012 FDA Red Flags Report are not all tipping point examples, but many are.
U.S. manufacturers have made a giant leap forward in protecting against cargo theft.
We've completed a major overhaul of FiercePharmaManufacturing's website. Drop us a line with any suggestions or comments you may have.
Take a look at a recent graph of health spending in the U.S., and you may see a visual metaphor for what faces drug manufacturing.