Elaine Yee-Ling Lai; Debarment Order.
(13NOV02) Click here for txt or pdf
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Robert A. Fiddes; Debarment Order.
(06NOV02) Click here for txt or pdf Prepublication display |
Delfina Hernandez; Debarment Order. (06NOV02) Click here for txt
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Diagnostic X-Ray Field Size; Revocation of Compliance Policy Guide 7133.17; Correction. (01NOV02) Click here for txt
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Agency Information Collection Activities; OMB Approval; Comment Request; State Enforcement Notifications. (31OCT02) Click here for txt
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Supporting Statement |
Diagnostic X-Ray Field Size; Revocation of Compliance Policy Guide 7133.17. (10OCT02) Click here for txt
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practices
and Related Regulations for Blood and Blood Components; and Lookback Requirements. (08OCT02) Click here for txt or pdf Prepublication display
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Class III Medical Devices Without Premarket Clearance; Revocation of Compliance Policy Guide 7124.30. (05SEP02) Click here for txt
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Draft Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator
Misconduct; Availability. (27AUG02)
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The Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice; Regulations
for Finished Pharmaceuticals. (27AUG02)
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Supporting Statement |
Advertisements for High-Intensity Mercury Vapor Discharge Lamps; Revocation of Compliance Guide 7133.13; Correction.
(25JUN02) Click here for txt
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Pharmacy compounding compliance policy guide. (07JUN02) Click here for txt
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Advertisements for High-Intensity Mercury Vapor Discharge Lamps; Revocation of Compliance Policy Guide 7133.13. (21MAY02) Click here for txt
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Sunlamp Product Performance Standard and UVA Tanning Products; Revocation of Compliance Policy Guide 7133.16. (21MAY02) Click here for txt
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Compliance Policy Guidance for FDA Staff and Industry on Blood Donor Classification Statement, Paid or Volunteer Donor;
Availability. (17MAY02) Click here for
txt or pdf
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The Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; CGMP Regulations for Finished
Pharmaceuticals. (16MAY02) Click here for txt or pdf
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Drug Manufacturing Inspections; Public Workshops; CORRECTION. (12APR02) Click here for txt
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Over-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Dates. (05APR02) Click here for txt
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Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Preliminary Draft Proposed Rule.
(01APR02) Click here for txt
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Preliminary Draft Proposed Rule |
Draft Revised Compliance Policy Guide; Male Condom Defects; Availability. (29MAR02) Click here for txt
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The Draft Guidance |
Drug Manufacturing Inspections; Public Workshops. (29MAR02) Click here for txt
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Anticaries Drug Products for Over-the-Counter Human Use; Use of Intraoral Appliance Models for Compliance with Biological
Testing Requirements; Request for Information and Comments; Reopening of Comment Period. (15MAR02) Click here for txt or pdf Prepublication display |
Small Entity Compliance Guide: "Structure/Function Claims;" Availability, correction by GPO (Government Printing
Office). There is no FDA pre-publication for display. (18JAN02) Click here for txt or pdf |