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------------------------------------------------------------------------Contents (.PDF) Federal RegisterContents (.TXT) Vol. 63, No. 223Thursday, November 19, 1998------------------------------------------------------------------------Food and Drug AdministrationRULESBioavailability and Bioequivalence Requirements; Abbreviated Applications; Proposed Revisions. Pages 64222-64228 [FR Doc. 98-30880] CDER 9470, Docket No. 98N-0778 [TXT] [PDF] NOTICESDanbury Pharmacal, Inc.; Withdrawal of Approval of 61 Abbreviated New Drug Applications. Pages 64266-64268 FR Doc. 98-30878] CDER 98169, Docket No. 98N-1000 [TXT] [PDF] Determination of Regulatory Review Period for Purposes of Patent Extension; Avapro. Page 64268 [FR Doc. 98-30990] OC 98389, Docket No. 98E-0781 [TXT] [PDF] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Pages 64268-64269 FR Doc. 98-30936] OC 98401 [TXT] [PDF] Agency Information Collection Activities; Announcement of OMB Approval; Premarket Notification Submission 510(k), Subpart E. Page 64269 [FR Doc. 98-30879] OC 98397, Docket No. 98N-0336 [TXT] [PDF] Agency Information Collection Activities; Announcement of OMB Approval; Supplements to Premarket Approval Applications for Medical Devices. Page 64269 [FR Doc. 98-30989] OC 98399, Docket No. 98N-0168 [TXT] [PDF] GUIDANCESDraft Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies--Study Design, Data Analysis, and Recommendations for Dosing and Labeling; Availability. Pages 64269-64270 [FR Doc. 98-30937] CDER 98124, Docket No. 98D-1001 [TXT] [PDF] The guidance documentDraft Guidance for Industry on Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation; Availability. Pages 64270-64271 [FR Doc. 98-30938] CDER 97204, Docket No. 98D-0997 [TXT] [PDF] The guidance document |