FEDERAL FOOD, DRUG, AND COSMETIC ACT

Analyses

Generic Drug Enforcement Act (S. 1164), S6698 [23MY]

Bills and resolutions

Amend (see H.R. 3216, H6381 [2AU])

———bottled water (see H.R. 3545, H7800 [10OC])

FDA: enforcement authority (see S. 2135, S18690 [27NO]; H.R. 3642, H8495 [24OC])

Food: definition of light butter (see H.R. 2596, H4186 [7JN])

———milk standards (see S. 1110, S6210 [21MY])

Health: require physicians who perform silicone gel implants to provide certain information to patients (see H.R. 1422, H1757 [13MR])

Pesticides: regulate chemical residues in food (see S. 1074, S5753 [14MY]; H.R. 2342, H3036 [14MY])

Pharmaceuticals: financial assistance to investigate RU-486 for Federal approval (see H.R. 798, H889 [5FE])

———penalties for illegal activities relative to the approval of abbreviated drug applications (see S. 1164, S6654 [23MY]; H.R. 2454, H3622 [23MY])

———protections against illegal activities involving drugs and medical devices (see S. 1982, S16942 [18NO])

———revise orphan drug provisions of law (see S. 2060, S18334 [26NO]; H.R. 3930, H11288 [25NO])

Safety: require food and drug manufacturers to maintain a toll-free telephone line for inquiries (see H.R. 509, H386 [11JA])

Descriptions

Generic Drug Enforcement Act (H.R. 2454), E1906 [23MY]

Generic Drug Enforcement Act (S. 1164), S6698 [23MY]

Letters

Orphan Drug Act amendments: National Organization for Rare Disorders, Inc., S18368 [26NO]

Remarks in House

Amend (H.R. 3216), E2882, E2932 [2AU]

Food: regulate pesticide chemical residues (H.R. 2342), E1758 [14MY]

Pharmaceuticals: penalties for illegal activities relative to the approval of abbreviated drug applications (H.R. 2454), H8552, H8556, H8557 [28OC], E1906, E1907 [23MY]

———revise orphan drug provisions of law (H.R. 3930), E4073 [25NO]

Remarks in Senate

FDA: enforcement authority (S. 2135), S18706 [27NO]

Food: milk standards (S. 1110), S6216 [21MY]

Pesticides: regulate chemical residues in food (S. 1074), S5796 [14MY]

Pharmaceuticals: penalties for illegal activities relative to the approval of abbreviated drug applications (S. 1164), S6694, S6699 [23MY]

———protections against illegal activities involving drugs and medical devices (S. 1982), S16943 [18NO]

———revise orphan drug provisions (S. 2060), S18366, S18369 [26NO]

Reports filed

Penalties for Illegal Activities Relative to the Approval of Abbreviated Drug Applications: Committee on Energy and Commerce (H.R. 2454) (H. Rept. 102-272), H8494 [24OC]

Summaries

Drug and Device Enforcement Act (S. 1982), S16946-S16948 [18NO]

Orphan Drug Act Amendments (S. 2060), S18368 [26NO]

Texts of

H.R. 2454, Generic Drug Enforcement Act, H8552-H8556 [28OC]

S. 1074, Safety of Pesticides in Food Act, S5797-S5802 [14MY]

S. 1164, Generic Drug Enforcement Act, S6694-S6698 [23MY]

S. 1982, Drug and Device Enforcement Act, S16943-S16946 [18NO]

S. 2060, revise orphan drug provisions, S18367 [26NO]