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Recently
Issued US Federal Register
New!
Training Course:
Quality System Regulation for the Medical Device & Biotech Industries
April 8 & 9, King of Prussia, PA. Organized by The Center for
Professional Innovation & Education.
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Notice: Determination That
DOVONEX (Calcipotriene) Ointment, 0.005%, Was Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
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Notice: CIBA Vision Corp.;
Withdrawal of Color Additive Petitions
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Notice: Training Program for
Regulatory Project Managers; Information Available to Industry
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Notice:
International Conference on Harmonisation;
Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals;
Availability
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Notice: Strengthening the
Center for Devices and Radiological Health's 510(k) Review Process;
Public Meeting; Extension of Comment Period
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Final Rule: Information on
Foreign Chain of Distribution for Ephedrine, Pseudoephedrine, and
Phenylpropanolamine
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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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Final Rule:
Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-The-Counter Human Use; Final Rule
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Notice: Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications; Availability
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Notice: Request for Measures of Patient Experiences of Cancer Care
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Notice: University of Arkansas; Notice of Decision on Applications for Duty-Free Entry of Scientific Instruments
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Notice: Advisory Committee
Information Hotline
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Notice: Submission for OMB
Review; Comment Request; Reinstatement of OMB No. 0925-0601/exp.
02/28/2010, Request for Human Embryonic Stem Cell Line To Be Approved
for Use in NIH Funded Research
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Notice:
Draft Guidance for Industry on
Non-Inferiority Clinical Trials; Availability
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Tissue Intended for
Transplantation
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Notice: Determination of
Regulatory Review Period for Purposes of Patent Extension; FIRMAGON
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Notice: Notice of Availability
Record of Decision for the Update to the Master Plan for the
Consolidation of the Food and Drug Administration Headquarters at the
Federal Research Center at White Oak in Silver Spring, MD
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Notice: Guidance for Industry
on Submission of Documentation in Applications for Parametric Release of
Human and Veterinary Drug Products Terminally Sterilized by Moist Heat
Processes; Availability
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Notice:
Draft Guidance for Industry on Adaptive
Design Clinical Trials for Drugs and Biologics; Availability
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Notice: Agency Information
Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Mental Models Study of Recruitment and
Retention of Pregnant Women Into An Asthma Pregnancy Registry
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Reporting and Recordkeeping
Requirements and Availability of Sample Electronic Products for
Manufacturers and Distributors of Electronic Products
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Notice: National Institutes of
Health Guidelines for Human Stem Cell Research
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Notice: Proposed Collection;
Comment Request; Investigating the Causes of Post Donation Information
(PDI): Errors in the Donor Screening Process
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Notice: Government-Owned
Inventions; Availability for Licensing
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Notice: Safety and Efficacy
Review for Additional Ingredients in Over-the-Counter Drug Products for
Human Use; Request for Environmental Impact Data and Information
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Notice: Saccharin from the
People's Republic of China: Final Results of Changed Circumstances
Review
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Proposed Rule: Reporting Information
Regarding Falsification of Data
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Notice: Office of the Commissioner Reorganization; Statement of
Organizations, Functions, and Delegations of Authority (*Large Document,
Linked Directly to Federal Register Website)
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Notice: Submission for OMB Review; Comment Request; The Atherosclerosis Risk
in Communities Study (ARIC)
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Exception From General
Requirements for Informed Consent
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Notice:
Agency Information Collection Activities;
Submission for Office of Management and Budget Review; Comment Request;
Antimicrobial Animal Drug Distribution Reports Under Section 105 of the
Animal Drug User Fee Amendments of 2008
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Notice: Agency Information
Collection Activities; Proposed Collection; Comment Request; Guidance
for Industry on How to Submit a Protocol Without Data in Electronic
Format to the Center for Veterinary Medicine
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Notice:
Agency Information Collection Activities;
Proposed Collection; Comment Request; Agreement for Shipment of Devices
for Sterilization
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Notice:
Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Guidance for
Humanitarian Device Exemption Holders, Institutional Review Boards,
Clinical Investigators, and
Food and Drug
Administration Staff: Humanitarian Device Exemption Regulation:
Questions and Answers; Availability
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Notice: Medical Devices
Regulated by the Center for Biologics Evaluation and Research;
Availability of Summaries of Safety and Effectiveness Data for Premarket
Approval Applications
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Notice: Regulatory Site Visit
Training Program
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Notice: Deposit of Biological
Materials
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Notice:
Post Allowance and Refiling
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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
-
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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