Pharmaceutical and Medical Device Safety : A Study in Public and Private Regulation /: A Study in Public and Private Regulation. (2019)

• Record Type: Book
• Further Information: Note: Sonia Macleod, Sweta Chakraborty.
• Authors: Macleod, Sonia; Chakraborty, Sweta
• Contents: 1. IntroductionI. The Legal ContextA. Basis of Liability B. Litigation Systems C. Funding and Costs D. US: The Class Action and MDL E. Europe F. Settlement Schemes 2. The Regulation of Medicines and Medical Devices I. Medicinal Products A. Historical Drug/Pharmaceutical Regulation in the UK B. European Regulation of Medicinal Products C. European Regulation of Medical Devices D. General Product Safety Regulation in Europe E. Medicinal Product Regulation in the US F. US Regulation of Medical Devices 3. Detailed Case Descriptions and Regulatory Histories I. Teratogens and Foetal Damage A. Thalidomide (alpha-phthalimido-glutarimide) B. Hormonal Pregnancy Tests – Including Primodos C. Diethylstilboestrol (DES) D. Epilim/Depakote/Depakene (sodium valproate, valproic acid, magnesium valproate, valproate semisodium or valpromide) E. Accutane/Roaccutane (isotretinoin) II. Contraceptives and Hormone Replacement Therapy A. Gravigard or Copper 7 Intrauterine DeviceB. Third-Generation Oral Contraceptives C. Norplant (levonorgestrel) D. Hormone Replacement Therapy III. Vaccines A. DTP Vaccine B. MMR Vaccine IV. Neuromodulators A. Benzodiazepines B. Merital (nomifensine) C. Selective Serotonin Reuptake Inhibitors D. Sabril (vigabatrin) E. Mirapexin/Sifrol/Daquiran (pramipexole) V. Non-Steroidal Anti-Inflammatories A. Opren (benoxaprofen) B. Vioxx (rofecoxib) VI. Pancreatic Function (Endocrine and Exocrine) and Obesity Treatments A. Adifax/Isomeride/Redux (dexfenfluramine) and Ponderax (fenfluramine) B. Mediator (benfluorex) C. Human Insulin D. Pancreatic Enzymes VII. Contaminated Human-Tissue-Derived ProductsA. Blood Products B. Human Growth Hormone VIII. Cardiovascular Pharmaceuticals A. Eraldin (practolol) B. Manoplax (flosequinan)C. Lipobay (cerivastatin) IX. Anti-Protozoan Medications A. Emaform, Entero-Form or Chinoform (clioquinol) B. Lariam (mefloquine) X. Breast and Other Cosmetic Implants A. Dow-Corning Silicone Implants B. Trilucent Breast Implants C. Poly Implant Prothese (PIP) Hydrogel Breast Implants D. Poly Implant Prothese (PIP) IMGHC Silicone Breast Implants XI. Urinary Incontinence and Pelvic Prolapse Treatments A. Micturin (terodiline) B. Urogynaecological Mesh 4. Conclusions I. Prevention is Better than a Cure II. Adverse Event Reporting III. Correlation or Causation?IV. Thresholds V. Product Withdrawals VI. Compensation or Redress? VII. Public Regulation v Private Regulation A. Compensation – Redress B. Deterrence VIII. Conclusions.
• Publisher Details: London : Hart/Beck
• Publication Date: 2019
• Extent: 1 online resource (320 pages)
• Subjects: Consumer protection law; Law -- Alternative Dispute Resolution; Law -- Arbitration, Negotiation, Mediation; Law -- Personal Injury; Arbitration, mediation & alternative dispute resolution
• Languages: English
• ISBNs: 9781509916733; 1509916733
• Related ISBNs: 9781509916696
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.