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Full Text of this Amendment
At the appropriate place, insert the following:
SEC. __. REQUIREMENT TO DOCUMENT CONTACT WITH DRUG SPONSORS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 251, is further amended by adding at the end the following:
``(r) Requirement to Document Contact With Drug Sponsor.--Each employee of the Food and Drug Administration shall document, in writing, each communication or contact, and the purpose of such communication or contact, that such official has with a sponsor of a drug for which an application is filled pursuant to subsection (b) or (j).''.
(As printed in the Congressional Record for the Senate on May 1, 2007.)