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Recently
Issued US Federal Register
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Notice: Guidance for Industry
and Food and Drug Administration; Guidance for the Use of Bayesian
Statistics in Medical Device Clinical Trials; Availability
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Notice:
Guidance for Industry on the Contents of a
Complete Submission for the Evaluation of Proprietary Names;
Availability
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Notice:
Agency Information Collection Activities;
Submission for Office of Management and Budget Review; Comment Request;
Recommendations for Clinical Laboratory Improvement Amendments of 1988
Waiver Applications
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Postmarket Surveillance
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Notice:
Agency Information Collection Activities; Proposed
Collection; Comment Request; Guidance for Industry on How to Submit
Information in Electronic Format
to the Center for
Veterinary Medicine Using the Food and Drug Administration Electronic
Submission Gateway
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Notice: Part C Early
Intervention Services Grant Under the Ryan White HIV/AIDS Program
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Notice:
Workshop on Pediatric Neurological and
Neurocognitive Assessments for Cardiovascular Devices; Public Workshop
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Notice: Interim Procedure for
Patentees To Request a Recalculation of the Patent Term Adjustment To
Comply With the Federal Circuit Decision in Wyeth v. Kappos Regarding
the Overlapping Delay Provision of 35 U.S.C. 154(b)(2)(A)
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Notice: Extension of the
Patent Application Backlog Reduction Stimulus Plan
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Notice (A): Government-Owned Inventions; Availability for Licensing
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Notice (B): Government-Owned
Inventions; Availability for Licensing
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Notice (C): Government-Owned
Inventions; Availability for Licensing
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Notice: Guidance for Industry
on the Use of Mechanical Calibration of Dissolution Apparatus 1 and
2--Current Good Manufacturing Practice; Availability
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Notice: Draft Guidance for
Industry on Assessment of Abuse Potential of Drugs; Availability
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Export of
Medical Devices-Foreign Letters of Approval
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Notice:
Agency Information Collection Activities; Proposed Collection; Comment
Request; General Licensing Provisions: Biologics License Application,
Changes to an Approved
Application, Labeling, Revocation and Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h and 2567
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Notice: NIH Consensus
Development Conference on Vaginal Birth After Cesarean: New Insights;
Notice
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Notice: International
Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety
Studies for the Conduct of Human Clinical Trials and Marketing
Authorization for Pharmaceuticals; Availability
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Notice:
Claims of Confidentiality of Certain Chemical
Identities Submitted under Section 8(e) of the Toxic Substances Control
Act
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Notice: Draft Guidance for
Industry and Food and Drug Administration Staff; Heart Valves --
Investigational Device Exemption (IDE) and Premarket Approval (PMA)
Applications; Availability
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Notice: Prospective Grant of
Exclusive License: Monoclonal Antibodies Against Smallpox/Orthopoxviruses
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Notice: NIH
State-of-the-Science Conference: Preventing Alzheimer's Disease and
Cognitive Decline; Notice
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Records and Reports Concerning Experience With
Approved New Animal Drugs; Adverse Event Reports on Forms FDA 1932,
1932a, and 2301
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Notice:
Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Guidance on
Informed Consent For In
Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are
Not Individually Identifiable
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Guidance on Reagents for Detection of Specific
Novel Influenza A Viruses
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Investigational Device Exemptions Reports and
Records
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Notice: Clinical Accuracy
Requirements for Point of Care Blood Glucose Meters; Public Meeting;
Request for Comments
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Notice: NIH Consensus
Development Conference: Lactose Intolerance and Health; Notice
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Notice: NIH
State-of-the-Science Conference: Enhancing Use and Quality of Colorectal
Cancer Screening
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Notice: Moving Into the
Future--New Dimensions and Strategies for Women's Health Research for
the National Institutes of Health; Notice
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Notice:
Publication of OIG Updated Special Fraud
Alert on Telemarketing by Durable Medical Equipment Suppliers
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Notice: Draft Guidance for
Institutional Review Boards, Clinical Investigators, and Sponsors: IRB
Continuing Review After Clinical Investigation Approval; Availability
- Interim Final Rule: Health
Information Technology: Initial Set of Standards, Implementation
Specifications, and Certification Criteria for Electronic Health
Record Technology; Interim Final Rule (*Large Document, Linked Directly
to Federal Register Website)
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Notice: Prospective Grant of
Exclusive License: Development of V-ATPase Inhibitor Compounds for the
Treatment of Human Cancers and Osteoclastic Bone Diseases Excluding
Rheumatoid Arthritis and Other Osteo-Specific Auto-Immune Diseases
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Presidential Document:
Proclamation 8472--National Influenza Vaccination Week, 2010
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Notice: Medical Trade Mission
to India: March 8-13, 2010
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Notice: Draft Guidance for
Industry on Planning for the Effects of High Absenteeism to Ensure
Availability of Medically Necessary Drug Products; Availability
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Notice: HHS Intent To Publish
Grant and Contract Solicitations for Comparative Effectiveness Research
(CER) Projects With Funds Allocated to the Office of the Secretary From
the American Recovery and Reinvestment Act (ARRA)
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Notice: Government-Owned
Inventions; Availability for Licensing
-
Notice: Guidance for Industry
on New Contrast Imaging Indication Considerations for Devices and
Approved Drug and Biological Products; Availability
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Executive Order: Establishing Federal
Capability for the Timely Provision of Medical Countermeasures Following
a Biological Attack
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Notice: Event Problem Codes
Web Site; Center for Devices and Radiological Health; Availability
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Notice:
Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Experimental
Study: Presentation of
Quantitative Effectiveness Information to Consumers in
Direct-to-Consumer Television and Print Advertisements for Prescription
Drugs
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Environmental Impact Considerations
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Notice: Medical Device
Quality System Regulation Educational Forum on Risk Management Through
the Product Life Cycle; Public Workshop
-
Notice: Approval for Expansion
of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular
Diagnostic Products), Chicago, IL, Area
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Notice (A): Government-Owned Inventions; Availability for Licensing
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Notice (B): Government-Owned Inventions; Availability for Licensing
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Notice (C): Government-Owned Inventions; Availability for Licensing
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