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  Federal Register  


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.
 

 

  1. Notice: Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
     
  2. Notice: CIBA Vision Corp.; Withdrawal of Color Additive Petitions
     
  3. Notice: Training Program for Regulatory Project Managers; Information Available to Industry
     
  1. Notice: International Conference on Harmonisation; Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability
     
  1. Notice: Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension of Comment Period
     
  2. Final Rule: Information on Foreign Chain of Distribution for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
     
  3. Notice (A): Government-Owned Inventions; Availability for Licensing
     
  4. Notice (B): Government-Owned Inventions; Availability for Licensing
     
  5. Notice (C): Government-Owned Inventions; Availability for Licensing
     
  1. 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
     
  2. 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
     
  3. Notice: Request for Measures of Patient Experiences of Cancer Care
     
  4. Notice: University of Arkansas; Notice of Decision on Applications for Duty-Free Entry of Scientific Instruments
     
  1. Notice: Advisory Committee Information Hotline
     
  2. 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
     
  1. Notice: Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability
     
  2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
     
  3. Notice: Determination of Regulatory Review Period for Purposes of Patent Extension; FIRMAGON
     
  4. 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
     
  1. 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
     
  2. Notice: Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability
     
  3. 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
     
  4. 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
     
  1. Notice: National Institutes of Health Guidelines for Human Stem Cell Research
     
  2. Notice: Proposed Collection; Comment Request; Investigating the Causes of Post Donation Information (PDI): Errors in the Donor Screening Process
     
  3. Notice: Government-Owned Inventions; Availability for Licensing
     

February 22, 2010

  1. Notice: Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human Use; Request for Environmental Impact Data and Information
     
  2. Notice: Saccharin from the People's Republic of China: Final Results of Changed Circumstances Review
     
  1. Proposed Rule: Reporting Information Regarding Falsification of Data
     
  2. Notice: Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority (*Large Document, Linked Directly to Federal Register Website)
     
  3. Notice: Submission for OMB Review; Comment Request; The Atherosclerosis Risk in Communities Study (ARIC)
     

February 18, 2010

  1. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Exception From General Requirements for Informed Consent
     
  2. 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
     
  3. 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
     
  4. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
     
  5. 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
     
  1. Notice: Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
     
  2. Notice: Regulatory Site Visit Training Program
     
  3. Notice: Deposit of Biological Materials
     
  4. Notice: Post Allowance and Refiling
     

February 8, 2010

  1. Notice: Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials; Availability
     
  2. Notice: Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability
     
  3. 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
     

February 5, 2010

  1. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance
     
  2. 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
     
  1. Notice: Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
     
  1. Notice: Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices; Public Workshop
     
  1. 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)
     
  2. Notice: Extension of the Patent Application Backlog Reduction Stimulus Plan
     
  1. Notice (A): Government-Owned Inventions; Availability for Licensing
     
  2. Notice (B): Government-Owned Inventions; Availability for Licensing
     
  3. Notice (C): Government-Owned Inventions; Availability for Licensing
     
  1. Notice: Guidance for Industry on the Use of Mechanical Calibration of Dissolution Apparatus 1 and 2--Current Good Manufacturing Practice; Availability
     
  2. Notice: Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability
     
  1. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices-Foreign Letters of Approval
     
  2. 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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