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Glossary Beta blocking agent: drugs that prevent the release of adrenaline and therefore may cause bradycardia (slowing of the heart), decreased cardiac output, and lowered blood pressure. Claims-made liability policy: policy that covers claims filed within the policy period for injuries that occurred during the policy period or within the retroactive period defined by Be policy. Clinical trial: a study of a drug or device (or drugs or devices) in human beings; it is usually intended to assess safety, effectiveness, route of administration, dosage, or other aspects of the drug or device. Compensatory damages: such damages that compensate an injured party for the injury sustained. Comprehensive general liability insurance: insurance that covers indemnity payments and legal expenses arising from a range of liabilities, including products liability. Ectopic pregnancy: development of He fertilized ovum outside Be uterine cavity. Effective patent life: Be length of time from Be date of FDA approval until Be date of patent expiration. Endometrium: the mucous membrane lining the uterus. Epididymis: the structure in the testes in which the spermatozoa are stored. Estrogen: female sex hormone produced by the ovary and responsible for Be development of female secondary sex characteristics; it also stimulates the growth of the endome~ium during the menstrual cycle and is used to stop lactation and suppress ovulation. 177

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}78 GLOSSARY Grandfather provisions: an exception to a restriction that allows all those already doing something to continue doing it, even if they would be stopped by the new restriction. Investigational Device Exemption (IDE): an exemption that FDA issues permitting manufacturers of devices intended solely for investigational use to distribute these devices for such use on human subjects. Investigational New Drug Application (IND): an application that a drug sponsor must submit to FDA before beginning tests of a new drug on humans. The IND contains the plan for the study as well as the drug's manufacturing information, structural formula, and animal test results. Compare New Drug Application. Institutional review board (IRB): a committee of experts and lay persons at a hospital or research institution that, in the interest of protecting human subjects, reviews clinical research before it begins and as it progresses. Insurance sublines: see Long-tailed lines of insurance. In vitro fertilization: fertilization of an ovum outside the body in an artificial environment (such as a test tube). Joint underwriting association (JUA): an incorporated association of insurance companies formed under statutory guidelines to provide a particular form of insurance to the public that is not readily available in the voluntary insurance market. All insurers operating in a state are required to participate as a condition of writing other coverages. JUA rates are regulated by state authorities. Deficits are usually funded by an assessment on participating insurers. Learned intermediary rule: a common law rule under which a manufacturer of a prescription drug has discharged its duty to warn the consumer if it informs the medical profession, including both prescribing and treating physicians, of potential risks and contraindictions. Long-tailed lines of insurance: lines of insurance for which several years may elapse between the alleged harmful act and the final disposition of all related claims, due to delay in the manifestation of the injury and in the disposition of the claims. Long-tailed liability claims may be separated from the circumstances that caused them by 25 years or more-e.g., diethylstilbestrol (DES)-related and asbestos-related claims. Mutual insurance companies: insurance companies in which the policy holders have ownership and control. New Chemical Entity (NCE): a pharmaceutical preparation that is the subject of a New Drug Application and whose active ingredient has not previously been the subject of such an application. New Drug Application (NDA): an application requesting FDA approval to market a new drug for human use. The application consists principally of data from clinical trials and animal studies, which are evaluated from specific technical perspectives-chemistry, pharmacology, medical, statistics, and microbiology. Compare Investigational New Drug Application.

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GLOSSARY ~ 79 Occurrence liability policy: an insurance policy that covers claims no matter when they are filed, as long as the injury occurred during the period the policy was in effect Pelvic inflammatory disease (PID): ascending infection from the vagina or cervix to the uterus, fallopian tubes, and broad ligaments. Preclinical trial: studies that test a drug in animals and other nonhuman test systems. Premarketing approval (PMA): a private license granted to the applicant for marketing a particular medical device. Products liability: legal responsibility of manufacturers and sellers to compensate buyers, users, and even bystanders for damages or injuries suffered because of defects in goods purchased. Products liability insurance: liability coverage that protects manufacturers and suppliers from claims for accidents arising from the use of their products. Professional liability insurance policy: insurance against claims for damages arising from professional activities of physicians, lawyers, accountants, and other professionals. Progesterone: the hormone that prepares the uterus for the reception and development of the fertilized ovum. Progestin: name used for certain synthetic or natural progesterones. Prostaglandin: a group of naturally occurring, chemically related, long-chain hydroxy fatty acids that stimulate contractility of the uterine and other smooth muscles. Proximate cause: the legally recognized cause of an injury or an event. Pulmonary embolism: obstruction or occlusion of the pulmonary artery or one of its branches by a clot or foreign material derived from elsewhere in the body. Punitive damages: damages awarded to injured party that are designed to punish a wrongdoer rather than simply compensate the injured party. Reanastomosis: surgical operation to reverse tubal sterilization or vasectomy. Restatement (Second) of Torts: a summary and explanation of major principles of contemporary tort law by the American Law Institute. Risk retention groups: groups formed to pool and insure risk by setting aside their own money rather than buying insurance from an outside source. Self-insurance: plan in which the insured sets aside sufficient sums to cover expected losses that may be sustained. Sperm antigens: substances on or in the sperm that in certain circumstances elicit the production of antibodies. Statutory law: body of law derived from legislative acts or statutes. Strict liability: a concept in which a manufacturer or seller of a product is liable for any and all defective or hazardous conditions associated with the product that unduly threaten a consumer's personal safety, regardless of the care taken in product development and distribution.

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~ 80 GLOSSARY Tail coverage: liability insurance that covers claims reported beyond the end of the policy period of a liability insurance policy written on a claims-made basis. Testosterone: the hormone produced by the testes responsible for inducing and maintaining male secondary sex characteristics. Third party coverage: insurance indemnifying the insured with respect to any loss that might be sustained as a result of his or her legal liability to others. Tort law: law surrounding a private or civil wrong or injury, other than breach of contract, for which the court will provide a remedy in the form of an action for damages. Toxicological testing: the testing of a substance in animals or other nonhuman test systems in order to assess its toxic or otherwise harmful effects. Transdermal patches: patches impregnated with pharmaceutical agents that are placed on the skin as a system for sustained delivery of a medicament into the bloodstream. Uniform Commercial Code: one of the uniform laws governing commercial transactions (e.g., sale of goods, commercial paper, investment securities). Virucide: a chemical agent that neutralizes or destroys a virus.