Political Quotes

“Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with. The PRESIDING OFFICER. Without objection, it is so ordered. The amendment is as follows: (Purpose: To require an independent assessment of the Food and Drug Administration's review of drug applications) At the end of title VII, add the following: SEC. 7__. INDEPENDENT ASSESSMENT. (a) In General.--The Secretary shall contract with a private, independent consulting firm capable of performing the technical analysis, management assessment, and program evaluation tasks required to conduct a comprehensive assessment of the process for the review of drug applications under subsections (b) and (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (j)) and subsections (a) and (k) of section 351 of the Public Health Service Act (42 U.S.C. 262(a), (k)). The assessment shall address the premarket review process of drugs by the Food and Drug Administration, using an assessment framework that draws from appropriate quality system standards, including management responsibility, documents controls and records management, and corrective and preventive action. (b) Participation.--Representatives of the Food and Drug Administration and manufacturers of drugs subject to user fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.…”