One approach to ensuring manufacturing quality would be to require manufacturers to implement quality systems that detail management responsibilities, risk management practices, su...
More must also than done to ensure transparency and access to information for products being imported into the United St...
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?
Is that sufficient or not?
Do you need additional authorities to be effective in that?
I commend you for the hearing today with regard to the FDA amendments that we are discussing with regard to PDUFA.
These are authorities that would be given FDA under H.R. 1483, the drug safety bill I introduced with my colleagues Mr. ...
Commonsense authorities, like mandatory recalls, subpoena power, ability to seize and destroy imported drugs and raw mat...
I would hope that we would follow the example that we set last Congress when we worked together in a remarkably bipartis...
Do you have the authority and the resources you need to address the safety of components now being imported into this co...