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
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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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