2001

International Conference on Harmonisation; Guidance on M4 Common Technical Document; Availability.    (16OCT01)
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The Guidance M4: Organization of the CTD                                                                                   M4E: The CTD-Efficacy                                                                                                                               M4Q The CTD-Quality                                                                                                                                                         M4S: The CTD-Safety                                                                                                                       M4S: The CTD-Safety Appendices

Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Medicated Feeds.    (15OCT01)
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Supporting Statement

Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Type A Medicated Articles.    (12OCT01)
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Supporting Statement

Agency Information Collection Activities; Announcement of OMB Approval; Good Laboratory Practices (GLP) Regulations for Nonclinical Laboratory Studies.    (12OCT01)
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Supporting Statement

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections Under United States/European Community Mutual Recognition Agreement.    (05OCT01)
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Agency Information Collection Activities; Announcement of OMB Approval; Voluntary Registration of Cosmetic Product Establishments.    (31AUG01)
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Supporting Statement

"Index and Copies of Presiding Officer Reports and Commissioner Decisions on the Eligibility of a Clinical Investigator to Continue to Receive Investigational Products; Availability.    (28AUG01)
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The index

Agency Information Collection Activities; Announcement of OMB Approval; Medical Devices; Current Good Manufacturing Practice (CGMP), Quality System (QS) Regulation.    (20JUL01)
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Supporting Statement

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Good Laboratory Practices (GLP) Regulations for Nonclinical Laboratory Studies.    (20JUL01)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles.    (15JUN01)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation. (31MAY01)
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Guidance for Industry on Ind Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information; Availability.    (25MAY01)
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The Guidance

Compliance Policy Guide: "Statement of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens;" Availability.    (03MAY01)
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The Guidance

Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practices (GLP) Regulations for Nonclinical Laboratory Studies. (30APR01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Institutional Review Boards.   (30MAR01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles.  (09FEB01)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds.  (09FEB01)
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Devices - Inspections of Medical Device Manufacturers Compliance Program Guidance Manual, CP 7382.845; Availability.  (07FEB01)
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The Guidance

Ashford Blood Bank, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0740-001.  (06FEB01)
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Regulatory Procedures Manual; Chapter 9: Import Operations/Action, Subchapter: Secured Storage; Availability.   (22JAN01)
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The Guidance

Draft Compliance Policy Guidance for FDA Employees and Industry on Blood Donor Incentives; Availability.  (16JAN01)
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Draft Guidance

Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement.   (08JAN01)
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