Good morning, Madam Chair and honourable members.
I'll answer the first question regarding the FDA. I think it's important to understand that there are no differing standards amongst what I would call the tier 1 regulators, whether it's the FDA, Health Canada, the European Union, or Australia, to name some of those.
What really happened, what triggered FDA's increased enforceability, and I think it may have been mentioned earlier on, resulted from the heparin contamination from a Chinese source that resulted in several deaths in the U.S., and very rapidly there was contaminated melamine in milk that also came from China. That coincided with the appointment of a new commissioner of the FDA, Dr. Margaret Hamburg. One of her first public speeches talked about increased enforceability to drug manufacturers, both branded manufacturers and generic manufacturers. That increased enforceability has really resulted in either mandated action imposed by the FDA as a result of warning letters and other instruments that are available to them, or voluntary action taken by the manufacturers to ensure that the products they are putting on the marketplace will meet the stricter enforceability compliance guidelines that the FDA imposed and other regulatory agencies followed thereafter. The standard did not change.