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Kefauver–Harris Amendment
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval,Peltzman, Sam An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments The Journal of Political Economy, Vol. 81, No. 5. (Sep. - Oct., 1973), pp. 1051. required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications. Background The amendment was a response to the thalidomide tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. The bill by U.S. Senator Estes Kefauver, of Tennessee, and U.S. Representative Oren Harris, of Arkansas, required drug manufacturers to provide ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the food safety, safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford (chemist), Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New Drug Application
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug. Among facts needed for the application are: * Patent and manufacturing information * Drug safety and specific effectiveness for its proposed use(s) when used as directed * Reports on the design, compliance, and conclusions of completed clinical trials by the Institutional Review Board * Drug susceptibility to substance abuse, abuse * Proposed labeling (package insert) and directions for use Exceptions to this process include voter driven initiatives for Medical cannabis, medic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceuticals Policy
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products. Funding of research in the life sciences In many countries, an agency of the national government (in the U.S. the NIH, in the U.K. the MRC, and in India the DST) funds university researchers to study the causes of disease, which in some cases leads to the development of discoveries which can be transferred to pharmaceutical companies and biotechnology companies as a basis for drug development. By setting its budget, its research priorities and making decisions about which researchers to fund, there can be a significant impact on the rate of new drug development and on the disease areas in which new drugs are developed. For example, a major investment by the NIH ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of Therapeutic Goods
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia. The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be sold. There is usually some degree of restriction on the availability of certain therapeutic goods, depending on their risk to consumers. History Modern drug regulation has historical roots in the response to the proliferation of universal antidotes which appeared in the wake of Mithridates' death. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive 65/65/EEC1
Directive 65/65/EEC1 was the first European pharmaceutical directive. (Dated 26 January 1965.) Intention The directive was a reaction to the Thalidomide tragedy in the early 1960s, when thousands of babies were born with deformities as a result of their mothers taking the drug during pregnancy. The directive aimed at harmonising standards for the approval of medicines within the then European Economic Community Regulation The main article 3 of the directive requires that a ''Proprietary medicinal product'' could not be marketed within the community without prior authorisation of the competent authority of at least one member state. ''Proprietary medicinal product'' being defined as "Any ''ready-prepared'' medicinal product placed on the market under a ''special name'' and in a ''special pack''." See also * EudraLex * Kefauver Harris Amendment * Regulation of therapeutic goods * European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Uni ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Delaney Clause
The Food Additives Amendment of 1958 is a 1958 amendment to the United States' Food, Drugs, and Cosmetic Act of 1938. It was a response to concerns about the safety of new food additives. The amendment established an exemption from the "food additive" definition and requirements for substances "generally recognized as safe" by scientific experts in the field, based on long history of use before 1958 or based on scientific studies. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive. "Generally recognized as safe" Generally recognized as safe (GRAS) is a Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requir ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Johns Hopkins School Of Medicine
The Johns Hopkins University School of Medicine (JHUSOM) is the medical school of Johns Hopkins University, a private research university in Baltimore, Maryland. Established in 1893 following the construction of the Johns Hopkins Hospital, the school is known for being a center of biomedical research and innovation, and is routinely ranked as one of the top medical schools in the United States. The School of Medicine is located in Baltimore, Maryland, where it shares a campus in East Baltimore with the School of Nursing, Bloomberg School of Public Health, and Johns Hopkins Hospital, the school's primary teaching hospital. As part of the larger Johns Hopkins Medicine health system, the school is also affiliated with numerous regional hospitals and medical centers including the Johns Hopkins Bayview Medical Center, Johns Hopkins Howard County Medical Center, Suburban Hospital in Montgomery County, Sibley Memorial Hospital in Washington, D.C. History Before his death in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Louis Lasagna
Louis Cesare Lasagna (February 22, 1923 – August 6, 2003) was an American physician and professor of medicine, known for his revision of the Hippocratic Oath. Early life and education Lasagna was an internationally recognized and respected expert in clinical pharmacology. Born in Queens, New York in 1923, Lasagna was raised in New Brunswick, New Jersey, by his Italian immigrant parents, and graduated from New Brunswick High School. He graduated from Rutgers University in 1943 and earned his medical degree from Columbia University in 1947. During his time at Rutgers University, he joined Kappa Sigma Fraternity (Gamma-Upsilon). After completing a clinical research fellowship in anesthesia at Harvard Medical School, Lasagna joined the faculty of Johns Hopkins University in 1954, where he established the first ever clinical pharmacology department. Lasagna taught medicine and pharmacology at Johns Hopkins until 1970, when he accepted the position as the first chairman of the Depa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Consumer Protection
Consumer protection is the practice of safeguarding buyers of goods and services, and the public, against unfair practices in the marketplace. Consumer protection measures are often established by law. Such laws are intended to prevent businesses from engaging in fraud or specified unfair practices to gain an advantage over competitors or to mislead consumers. They may also provide additional protection for the general public which may be impacted by a product (or its production) even when they are not the direct purchaser or consumer of that product. For example, government regulations may require businesses to disclose detailed information about their products—particularly in areas where public health or safety is an issue, such as with food or automobiles. Consumer protection is linked to the idea of consumer rights and to the formation of consumer organizations, which help consumers make better choices in the marketplace and pursue complaints against businesses. Entities ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Efficacy Study Implementation
Drug Efficacy Study Implementation (DESI) was a program begun by the Food and Drug Administration (FDA) in the 1960s after the requirement (in the Kefauver-Harris Drug Control Act) that all drugs be efficacious as well as safe, was made part of US law. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.Pharmacy Today. August 2008.FDA aims to remove unapproved drugs from market: Risk-based enforcement program focuses on removing potentially harmful products/ref> The Drug Efficacy Study Implementation (DESI) evaluated over 3,000 separate products and over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443 products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending. One of the early effects of the DESI study was the development of the Abbreviated New Drug Application (ANDA). See also * Estes Kefauver * Federal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Drug Reaction
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as ''pharmacovigilance''. An adverse event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. An ADR is a special type of AE in which a causative relationship can be shown. ADRs are only one type of medication-related harm. Another type of medication-related harm type includes not taking prescribed medications, known as non-adherence. Non-adherence to medications can lead to death and other negative outcomes. Adverse drug reactions require the use of a medication. Classific ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
