Claiborne Pell said "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?" @ PoliticalQuotes.com

On the recordJune 27, 1996

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?

Said by

Claiborne Pell

Democratic · Rhode Island

Source

govinfo.gov

Editor's note · Context

Clarifying language in an amendment regarding standards for substantial investment by generic drug companies.

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