Biotechnology Law Report
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Japanese Biotech Patenting Strategies in the Era of Follow-On Biologics
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 483-496. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Bibliography
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 529-530. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
On the Move
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 531-531. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Vermont Requires Full Disclosure of Payments to Healthcare Providers; Medicare Panel Wants Pathway for Follow-On Biologics; Sequenom Being Investigated by SEC over Down's Syndrome Test Problems; Amgen Pays Fine for Allegedly Overcharging
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 524-524. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Two Researchers Barred from Involvement in Clinical Trials; Enough, Already! The Scientist Says Some Who Are Guilty of Misconduct; Deserve a Second Chance; The Non-Expert Expert?; More Questions About Payments to Surgeon Researcher; Fake Paper Creates Questions About “Open Access” Journals; Elsevier Said to Have Published Eight Additional Journals with Undisclosed Drug Company Sponsorship; Transplantation Researchers Have 8-Year History of Fraud, ORI Says
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 525-528. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Two Researchers Barred from Involvement in Clinical Trials; Enough, Already! The Scientist Says Some Who Are Guilty of Misconduct; Deserve a Second Chance; The Non-Expert Expert?; More Questions About Payments to Surgeon Researcher; Fake Paper Creates Questions About “Open Access” Journals; Elsevier Said to Have Published Eight Additional Journals with Undisclosed; Drug Company Sponsorship Transplantation Researchers Have 8-Year History of Fraud, ORI Says
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 525-528. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 537-554. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Takeda Pharmaceutical Co., Ltd. v. John J. Doll, Acting Under Secretary of Commerce for Intellectual Property
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 555-561. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 532-536. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Double Patenting and Process Patents; Apparently, Oxford, U.K., Is Not in California; When Does the Two-Way Test for Obviousness Apply?; Illumina Sues for Infringement of Analytical Technology Patent; Ruling in Favor of Affymetrix Overturned; Abbott Ordered to Pay $1.67 Billion; BASF Sues Pioneer Hi-Bred for Unlawful Use of Technology; DuPont Countersues Monsanto; Beckman, Orchid, and Sequenom Suit Dropped
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 517-523. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
In re Frits Jacobus Fallaux, Robert Cornelius Hoeben, Alex Jan van der Eb, Abraham Bout, and Domenico Valerio
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 573-576. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
FDA Cannot Write Definitions on Its Own; APHIS Releases Biotechnology Quality Management System; Environmental Impact Statement Needed for Alfalfa; EU Finds Monsanto Corn Safe; High-Oleic Soybeans Okayed; Farmer Irritated with Biotechnology Opponents; Canada Drops Canola Complaint Against WTO; Cambridge to Ban Level 4 Laboratories; Restriction on Use of Antibiotics in Animal Field; Eight-Feature Corn Gets U.S., Canadian Approval
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 509-511. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Cardiac Stem Cell Trial to Proceed; Earlier Use of Drugs That Have Completed Clinical Trials; Harmonization of European Clinical Trial Rules Demanded
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 508-508. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Steps Taken to Prevent Federal Preemption; CAFC Finds Vaccine Did Cause Child's Injury
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 512-513. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
ACLU, Others Attack Patents on Breast Cancer Genes; PTO Upholds Patents on Uses of Stem Cells; Venture Capital Group Says 12 Years of Exclusivity Required for Biologics; DoJ Objects to Pay-to-Delay Agreements; EU Acts on Pay-to-Delay Issue; U.K. Minister Asks for Surrender of Patent Rights to Anti-HIV Drugs
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 514-516. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Comment on Getting Written Description Right in the Biotechnology Arts: A Realist Approach to Patent Scope
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 497-499. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Personalized Medicine: Planning for the Future Colloquium I: Diagnostics and Diagnoses, Paths to Personalized Medicine
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 500-502. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Guidance on Placement of Integrated Effectiveness and Safety Summaries; Advice from FDA on Presenting Risk Information; More Warnings for Erlotinib; Sanofi-Aventis Said to Overstate Efficacy of Docetaxel; Possible Dosage Alterations for Rituximab; FDA Establishes Transparency Task Force; Unauthorized Clinical Trials Alleged; FDA Should Release Information on Unapproved Uses; Pegylated Anti-TNF Product Closer to European Approval; Viral Contaminant Reducing Supplies of Replacement Enzymes; First Follow-On Biologic Approved in Japan; More Human Embryonic Stem Cell Lines May Be Approved for Research; All Genetic Tests and Performance Data Should Be Registered; Early Development of Biologics to Gain New Regulatory Body in India; Rapid Test for C. diff. Approved; Label Changes for Immunosuppressives Reflect Concern About Kidney Virus
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 503-507. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Autogenomics, Inc. v. Oxford Gene Technology Limited
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Biotechnology Law Report Aug 2009, Vol. 28, No. 4: 562-572. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - October 30, 2009 Category: Medical Law Tags: article Source Type: journals
Is the Gene Patenting Party Over? Biotechnology Patents After In re Kubin
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 329-331. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Revisions to Regulations on Importation, Movement, and Release of Genetically Engineered Organisms
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 344-344. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
GAO Finds Serious Problems with Oversight of Clinical Trials; Draft Guidance on Cell Therapy for Heart Disease; Texas May Require Insurance Coverage of Routine Medical Care for Patients; in Clinical Trials; Hsp90 Inhibitor to Begin Phase I Study; Phase I Trial of Lung Cancer Drug Expanded
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 342-343. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (Draft Report for Public Comment) [excerpts]
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 417-442. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Failure-to-Warn Prempro Case to Proceed; Class Action Status Denied in Vioxx Case
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 345-345. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Coming Events
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 478-481. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
CAFC Agrees Kubin Claims Are Obvious; Mixed Decision from CAFC on Changes Desired by PTO; Options for Patenting Genetic Tests; Roche Sues Mylan over Capecitabine Plans; Human Gene Patents Not as Toxic as Predicted; Pacific Biosciences Named Senior Party in Dispute with Life Technologies; Novocell Receives U.S. Endoderm Patent; Helicos to Appeal EPO Maintenance of Illumina Patent; Alnylam to Receive RNA Interference Patent; Mixed Decision in Compact Disk Dispute at ITC; Patent Misuse Defense Is One Issue
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 346-358. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Eli Lilly and Company v. Teva Pharmaceuticals USA, Inc. (2009-1071)
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 462-467. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
In re Marek Z. Kubin and Raymond G. Goodwin (2008-1184) (Serial no. 09/667,859)
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 409-416. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Triantafyllos Tafas and SmithKline Beecham Corporation (doing business as GlaxoSmithKline), SmithKline Beecham PLC, and Glaxo Group Limited (doing business as GlaxoSmithKline) v. John J. Doll (2008-1352)
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 443-461. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms [excerpts]
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 382-408. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
2009 Draft Guidelines on Human Stem Cell Research
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 378-381. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Lilly Entitled to Longer Protection of Raloxifene; Netherlands Removes Partial Patent Validity Law; Sanctionable Conduct Does Not Always Justify Award of Attorney Fees; Invitrogen–GE Healthcare Suit Sent to Texas; CAFC Rejects Appeal in HPV Case; Ariad, MIT Patent on Transcription Factor Fails Written Description Test; Motion for Summary Judgment of Non-Infringement Denied
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 359-365. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research, and The President and Fellows of Harvard College v. Eli Lilly and Company (2008-1248)
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 468-477. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
The EPO's Decision G 2/06 on the Patentability of Human Embryonic Stem Cells: Sounding the Bell for the Next Round?
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 332-337. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Obama Lays Out Procedures for Improving Scientific Integrity; Weill Medical College Fined over Inadequate Reporting of Scientist Workload; Former Bristol-Myers Executive Admits Attempting to Block Introduction of Generic Clopidogrel; Quest Diagnostics Settles over Diagnostic Kits; “Fake” Orthopedics Journal Revealed; Study Reporting Value of Bone Growth Protein Retracted
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 372-373. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Research on Human Embryonic Stem Cells Now Eligible for NIH Funding; Tort Reform Legislation Proposed in Georgia; Free Access Policy Made Permanent; Worries About Synthetic Bioweapons; Two Animal Rights Extremists Indicted; Two Genetic Tests Not Endorsed by CDC Group; What Regulation Is Needed for Genetic Testing?; Possible Criminalization of Stem Cell Research
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 368-371. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Medicare Considering Whether to Pay for Genetic Tests; Gifts and Consulting Fees Being Curtailed
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 366-367. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Recombinant Drug May Be Rationed; Ranbaxy Still in Trouble with FDA; FDA Joins Nanotechnology Review Body; New HPV Tests Approved; FDA Official Reminds Staff to Protect Information; Anti-IL-6 Drug Linked to Deaths; Genentech Withdraws Raptiva Monoclonal Antibody; FDA Finds Problems with Internet Drug Advertisements
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 339-341. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
On the Move
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 377-377. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
In re Gleave: Anticipation of Genus by Prior Art Species in Long List
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 338-338. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
Bibliography
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Biotechnology Law Report Jun 2009, Vol. 28, No. 3: 374-376. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - August 1, 2009 Category: Medical Law Tags: article Source Type: journals
The Industrial Applicability of Biotechnology Patents—A New Test for Europe
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 151-158. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
Coming Events
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 323-327. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
Pfizer Said to Be Guilty of Trade Secret Violations; NEJM Revises Disclosure Rules; Harvard Reviews Conflict of Interest Rules Again; PhRMA Bans Gifts; Massachusetts Biotechnology Chief Faces $10,000 Ethics Fine; Japanese Postdoc May Have Been Guilty of Misconduct
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 189-190. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
Some Scientists Concerned About Dual-Use Research; Animal Rights Activists Convicted of Blackmail, Terroristic Threats; Paper Removed for Possible Defamation; Are Restrictions on Industry Ties to Physicians Costing Boston Money?
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 187-188. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
On the Move
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 195-196. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
Bibliography
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 191-194. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 227-240. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
Wyeth v. Diana Levine (No. 06-1249)
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 197-226. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
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Biotechnology Law Report Apr 2009, Vol. 28, No. 2: 241-258. (Source: Biotechnology Law Report)
Source: Biotechnology Law Report - May 15, 2009 Category: Medical Law Tags: article Source Type: journals
