PRESCRIPTION DRUG USER FEE ACT

Amendments

FDA: modernize (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, FDA Modernization and Accountability Act, S11018 [23OC], H8978 [22OC]

Bills and resolutions

FDA: modernize (see S. 830), S5341 [5JN]

———modernize (S. 830), corrections in enrollment (see S. Con. Res. 69), S12576 [13NO], H10955 [13NO]

Cloture motions

FDA: modernize (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

FDA Modernization and Accountability Act: Daniel E. Lungren and Theodora Berger, S8867 [5SE]

———Donna E. Shalala, Sec. of HHS, S8843 [5SE]

———Tom Carper, Governor of Delaware, and Tom Ridge, Governor of Pennsylvania, S8855 [5SE]

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 and Drug Administration Modernization and Accountability Act: Donna E. Shalala, Sec. of HHS, S12654-S12656 [13NO]

Issuance of State warning labels or public warnings about over-the-counter drugs: James D. Cope, Nonprescription Drug Manufactures Association, S9845 [24SE]

Pharmaceutical and biological prescription drug industries user fees: Donna E. Shalala, Dept. of HHS, H10887 [13NO]

Motions

FDA: modernize (S. 830), H8500 [7OC]

Papers

Human Costs of Regulation—The Case of Medical Devices and the FDA: David C. Murray, Hudson Institution, S9833 [24SE]

Remarks in House

FDA: modernize (S. 830), H8482-H8500 [7OC], H8807 [9OC]

———modernize (S. 830), conference report, E2388 [13NO]

———modernize (S. 830), corrections in enrollment (H. Con. Res. 196), H10886-H10889 [13NO]

———modernize (S. 830), insert language of H.R. 1411 in lieu, H8500 [7OC]

Reauthorize, H8475-H8482 [7OC]

Remarks in Senate

FDA: approval process and development of new drugs and biological products, S2762-S2764 [7AP]

———drug manufacturing and pharmacy compounding regulations, S9839, S9840, S9849 [24SE]

———modernize (S. 830), S5342 [5JN], 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]

———modernize (S. 830), conference report, S12482 [10NO], S12653 [13NO]

———modernize (S. 830), corrections in enrollment (S. Con. Res. 69), S12710 [13NO]

———modernize (S. 830), unanimous-consent agreement, S8819 [4SE], S9362, S9378 [16SE], S9600, S9626 [18SE], S9754, S9759, S9760, S9769 [23SE], S10777 [9OC]

———modify mission statement, S9764 [23SE]

———prescription drug user fee reauthorization, S7942 [23JY], S8854-S8855, S8860 [5SE], S9838, S9840, S9842, S9844 [24SE]

———treatment of liability relative to adverse reaction reports or other certain information, S9764, S9765 [23SE]

Reports filed

FDA Modernization and Accountability Act: Committee on Labor and Human Resources (Senate) (S. 830) (S. Rept. 105-43), S6907 [7JY]

Statements

FDA Modernization and Accountability Act (S. 830): Committee on Labor and Human Resources (Senate), S9835-S9838 [24SE]

———OMB, S9848, S9849 [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, Food and Drug Administration Modernization and Accountability Act, H10886 [13NO]

S. 830, FDA Modernization and Accountability Act, S9133-S9145 [11SE], S9850-S9867 [24SE], H8482-H8500 [7OC]

S. Con. Res. 69, corrections in enrollment of S. 830, Food and Drug Administration Modernization and Accountability Act, S12616, S12710 [13NO]