It appears that the current attitude of FDA employees is more user friendly than it has been for years. This is good. However, those who are subject to regulation by the FDA must always recognize that it is their responsibility to comply with the law and it is FDA's responsibility to assure the public of compliance and pursue enforcement against those who do not comply. Ultimately, it is the nearly 10,000 FDA employees across the country who have the greatest impact on industry, not an individual commissioner. Industry executives will be wise to maintain focus on compliance and support those who are responsible to assure compliance with a reasonable interpretation of law and regulation.
History generally repeats itself and preparation for the storm is best done during the calm.