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  Biotechnology Law Report
  Volume 27, Number 5, October 2008
  homepage                   other issues
 
  • Challenges for Biotechnology Law
        Robert A. Bohrer
        p.421-424                                                                              +cite        

  • Regulatory Affairs—Pharmaceutical
  • FDA Seeks Quality Information; Legislative Filings to Overturn Preemption Decisions; Supreme Court Prepares To Hear Wyeth v. Levine; Generic Drug Company Runs Afoul of FDA; Approvable, Not Approvable System Being Replaced; New Guidance on Advisory Committees; GMPs No Longer Required for Phase I Biologics; Security to Be Improved at Advisory Committee Meetings; FDA Recommends Genetic Test Before Drug Use; Stronger Warning for TNF-Alpha Blockers; Changes Coming in Post-Approval Review No More “Throw the Drug over the Wall” and Wait; More Labeling Revisions for Tysabri, Epo; Information on Expensive Drugs Being Withheld; Patients Given Right to Be Told About Clinical Trials; Countries to Collaborate on Drug Facility Inspections; California Tries to Halt DTC Genetic Test Sales; PhRMA Revises Marketing Recommendations; Transplant Tourism Decried; Stanford Restricts Use of Drug Company Money for Medical Education; Labeling for Hormone Replacement Therapy Found Adequate
        p.425-433                                                                              +cite    

  • Clinical Trials
  • Company Ordered to Admit Patient to Trial; Company Shows Bioequivalence of Possible Follow-On Biologic
        p.434                                                                                      +cite    

  • Regulatory Affairs—Agricultural and Environmental
  • Class Action for Rice Contamination Suit Denied; Bt Vip3Aa Proteins Exempted; Free Speech Permits Use of Inaccurate Term; USDA Analyzes Traceability and Labeling Requirements
        p.435-436                                                                              +cite    

  • Patents
  • BLR Update: Thomson Patents Stand
        p.437                                                                                      +cite    

  • Patent Litigation
  • Stanford's Patents for HIV Monitoring Are Obvious; NP Test Said to Infringe; MIT Sues Affymetrix over GeneChip Products
        p.438-440                                                                              +cite    

  • Financial and Shareholder Affairs
  • EC Pursues Parallel Trade; Scientist Wants Royalties; Selden to Pay SEC Fine
        p.441                                                                                      +cite    

  • Misconduct
  • BLR Update: “Serious Problems” Identified in Stem Cell Trial; Researcher Does Not Disclose Patent in Paper; Payment from Sponsor Was Reported; Patent Disclosed to NIH and FDA
        p.442                                                                                      +cite    

  • On the Move
  • On the Move
        p.443                                                                                      +cite    

  • Texts
  • Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program
        p.444-446                                                                              +cite    
  • Wyeth, Petitioner v. Diana Levine, Respondent: Brief for the United States as Amicus Curiae Supporting Petitioner
        p.447-458                                                                              +cite    
  • Brief of Amici Curiae Former FDA Commissioners Dr. Donald Kennedy and Dr. David A. Kessler in Support of Respondent
        p.459-468                                                                              +cite    
  • Brief of Amici Curiae Members of Congress in Support of Respondent
        p.469-480                                                                              +cite    
  • Brief of Amici Curiae Vermont et al. in Support of Respondent
        p.481-495                                                                              +cite    
  • Global Traceability and Labeling Requirements for Agricultural Biotechnology-Derived Products: Impacts and Implications for the United States
        p.496-498                                                                              +cite    
  • Memorandum & Order: Re: Defendants' Motion for Summary Judgment on Invalidity of Patents, The Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., et al.
        p.499-520                                                                              +cite    
  • Coming Events
        p.521-524                                                                              +cite