I would like to clarify my understanding of some language contained in section 2(B) of the section of the pending amendment entitled Determination of Substantial Investment. It is my understanding that this section of the legislation is meant to simply set a standard for a determination of "substantial investment" by a generic drug company at a level higher than the simple completion of paperwork and testing necessary for filing of an application submitted under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act, the so-called ANDA, to the FDA. Is that so?
Claiborne Pell: “I would like to clarify my understanding of some language contained in section 2(B) of the section of the pending…”
Editor's note · Context
Clarifying language in an amendment regarding standards for substantial investment by generic drug companies.
Share
More from Claiborne Pell
I rise to support the Senator from Massachusetts and the Senator from Louisiana. I think that Harry Wu has been treated in a dreadful manner. We all agree with that. Of even greater importance is the relationship with China. I am reminded…
To be perfectly clear then, under the amendment, generic drug companies will be able to use all of the information contained in their ANDA, in addition to any other evidence they wish, to assist in proving their claim of ``substantial…
I congratulate him, too, on his prescience in evaluating the long-term viability of the Soviet system. He, and others, including George Kennan, saw that the Soviet system was so antinatural, so incapable of satisfying human needs that it…
We have heard the arguments pro and con. My own view, and I think the view of many of us, is that Mr. Brown fully matches the qualifications of his predecessors. He has demonstrated a capacity for leadership and for bringing people…





