FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT
Amendments
Enact (S. 830), S9219, S9236 [11SE], S9298 [12SE], S9338, S9340, S9341, S9342, S9343, S9344, S9345, S9346, S9350 [15SE], S9428 [16SE], S9705, S9707 [19SE], S9739, S9763, S9766, S9767 [23SE], S9849 [24SE]
Appointments
Conferees: S. 830, provisions, S11018 [23OC], H8978 [22OC]
Articles and editorials
Cyclosporiasis and Raspberrries—Lessons for the Future, S9825 [24SE]
Bills and resolutions
Enact (S. 830): corrections in enrollment (see S. Con. Res. 69; H. Con. Res. 196), S12576 [13NO], H10955 [13NO]
Chronologies
Advanced Breast Biopsy Instrumentation device application process, S9752 [23SE]
Cloture motions
Enact (S. 830), S8721 [3SE], S8821 [4SE], S8839 [5SE], S9146 [11SE], S9375 [16SE], S9632 [18SE]
Factsheets
Adverse Health Effects of Feminine Hygiene Products, S9149 [11SE]
FDA Modernization and Accountability Act and Preemption of Cosmetic Regulations by the States, S9149 [11SE]
Hazards of Skin Care Products Containing Alpha-Hydroxy, S9149 [11SE]
Talc May Pose a Risk of Ovarian Cancer, S9150 [11SE]
Letters
Cosmetic industry regulation: Cynthia A. Pearson, National Women's Health Network, S8882 [8SE]
FDA regulation of medical device approval process relative to labeling claims: George N. Hatsopoulos, Thermo Electron (business), S9749 [23SE]
———Monica Morrow, S9746 [23SE]
FDA regulation of medical device approval process relative to tracking or conducting of post-market surveillance: Elaine Levenson, Victims Against Lethal Valves (organization), S9708 [19SE]
FDA treatment of liability relative to adverse reaction reports or other certain information: Alan F. Holmer, Pharmaceutical Research and Manufacturers of America, S9765 [23SE]
Food irradiation disclosure requirements: several food and agricultural associations, S9826 [24SE]
Issuance of State warning labels or public warnings about over-the-counter drugs: James D. Cope, Nonprescription Drug Manufactures Association, S9845 [24SE]
National Center for Complementary and Alternative Medicine: Jordan J. Cohen, Association of American Medical Colleges, S9761 [23SE]
———several health care professionals and organizations, S9761 [23SE]
Pharmaceutical and biological prescription drug industries user fees: Donna E. Shalala, Dept. of HHS, H10887 [13NO]
Provisions: Daniel E. Lungren and Theodora Berger, S8867 [5SE]
———Donna E. Shalala, Sec. of HHS, S8843 [5SE], S9817 [24SE], S12654-S12656 [13NO]
———Tom Carper, Governor of Delaware, and Tom Ridge, Governor of Pennsylvania, S8855 [5SE]
Memorandums
FDA Regulation of Laws on Tobacco Product Labeling, Advertising, and Marketing: Congressional Research Service, S8857-S8859 [5SE]
Motions
Papers
Human Costs of Regulation—The Case of Medical Devices and the FDA: David C. Murray, Hudson Institution, S9833 [24SE]
Remarks in House
Enact (S. 830), H8482-H8500 [7OC], H8807 [9OC]
———conference report, E2388 [13NO]
———corrections in enrollment (H. Con. Res. 196), H10886-H10889 [13NO]
———insert language of H.R. 1411 in lieu, H8500 [7OC]
Remarks in Senate
Cosmetics: regulation of cosmetic industry, S8840-S8842, S8845-S8847, S8860-S8869 [5SE], S8881-S8888, S8892-S8894 [8SE], S9146, S9150 [11SE]
Enact (S. 830), S8162-S8170, S8205 [28JY], S8482 [31JY], S8721 [3SE], S8815 [4SE], S8837-S8869 [5SE], S8878-S8898 [8SE], S9133-S9157 [11SE], S9360-S9363, S9378-S9385 [16SE], S9553, S9694-S9697 [18SE], S9701-S9713, S9721 [19SE], S9737-S9754, S9755-S9759-S9769, S9771-S9775, S9781 [23SE], S9811-S9868 [24SE], S10469 [7OC]
———conference report, S12482 [10NO], S12653 [13NO]
———corrections in enrollment (S. Con. Res. 69), S12710 [13NO]
———unanimous-consent agreement, S8819 [4SE], S9362, S9378 [16SE], S9600, S9626 [18SE], S9754, S9759, S9760, S9769 [23SE], S10777 [9OC]
FDA: drug manufacturing and pharmacy compounding regulations, S9839, S9840, S9849 [24SE]
———Federal requirements for labeling of nonprescription drugs, S9768, S9769 [23SE]
———food labeling relative to nutrition information, S9824 [24SE]
———labeling uniformity requirements relative to poison control, S9763 [23SE]
———modify mission statement, S9764 [23SE]
———prescription drug user fee reauthorization, S8854-S8855, S8860 [5SE], S9838, S9840, S9842, S9844 [24SE]
———regulation of medical device approval process, S8843-S8845, S8847-S8850, S8853, S8860-S8869 [5SE], S8888-S8890, S8895-S8898 [8SE], S9361, S9380-S9385 [16SE], S9701-S9705 [19SE], S9772-S9775 [23SE], S9831-S9835, S9848 [24SE]
———regulation of medical device approval process relative to conflict of interest standards of FDA employees, S9705-S9707 [19SE], S9737, S9738 [23SE]
———regulation of medical device approval process relative to labeling claims, S9710-S9712 [19SE], S9739-S9754, S9755 [23SE], S9814-S9819, S9827-S9831 [24SE]
———regulation of medical device approval process relative to tracking or conducting of post-market surveillance, S9708-S9710 [19SE], S9738, S9739 [23SE]
———regulation of tobacco products, S9766, S9767 [23SE]
———revise food irradiation disclosure requirements, S9824, S9825 [24SE]
———treatment of liability relative to adverse reaction reports or other certain information, S9764, S9765 [23SE]
NIH: establish National Center for Complementary and Alternative Medicine, S9759-S9762 [23SE]
Pharmaceuticals: establish financial incentives for testing the safety of drugs on children, S9823 [24SE]
States: issuance of warning labels or public warnings about over-the-counter drugs, S9844, S9845 [24SE]
Tobacco products: tobacco industry liability settlement relative to health risks and marketing and manufacturing practices, S8853, S8856, S8859 [5SE], S9246-S9248 [12SE]
Reports filed
Provisions: Committee on Labor and Human Resources (Senate) (S. 830) (S. Rept. 105-43), S6907 [7JY]
Statements
Provisions (S. 830): Committee on Labor and Human Resources (Senate), S9835-S9838 [24SE]
Regulation of Cosmetic Industry in Food and Drug Administration Modernization and Accountability Act: David Wallinga, Natural Resources Defense Council, S9148 [11SE]
Summaries
Prescription Drug User Fee Act Reauthorization Performance Goals and Procedures, H10887-H10889 [13NO]
Texts of
H. Con. Res. 196, corrections in enrollment of S. 830, provisions, H10886 [13NO]
S. 830, provisions, S9133-S9145 [11SE], S9850-S9867 [24SE], H8482-H8500 [7OC]
S. Con. Res. 69, corrections in enrollment of S. 830, provisions, S12616, S12710 [13NO]