The Combating Autism Act of 2006 consolidated and intensified the Federal effort to understand and treat autism spectrum...
HHS is a unified Department and its differing agencies should have the same strategic vision that is coordinated to achi...
I must say that I am disappointed with the Executive order's results.
Our goal has to ensure America remains the leader in medical innovation.
Regulatory relief is essential to a strong economic recovery and boosting job creation.
These are authorities that would be given FDA under H.R. 1483, the drug safety bill I introduced with my colleagues Mr. ...
I commend you for the hearing today with regard to the FDA amendments that we are discussing with regard to PDUFA.
One approach to ensuring manufacturing quality would be to require manufacturers to implement quality systems that detai...
Do you have the necessary authorities and resources to see to it that drugs are only imported from facilities overseas t...
Do you have the ability to fully control the safety of imported pharmaceuticals, yes or no?
Do you have the ability to see to it that raw-materials suppliers also engage in good manufacturing practices abroad?
Do you have the resources needed to conduct foreign drug-facility inspections with the same frequency as domestic drug-f...
More must also than done to ensure transparency and access to information for products being imported into the United St...
Do you need additional authorities to be effective in that?
Is that sufficient or not?
I have great concern for the tremendous amount of pharmaceutical medicines and ingredients that are coming in from abroa...
Are today's GMPs sufficient to ensure manufacturing quality, yes or no?
Do you have the authority and the resources you need to address the safety of components now being imported into this co...
