Glossary of Terms
The following is a helpful list of terms and acronyms, including brief descriptions:
Abbreviated New Drug Application
Contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Active Pharmaceutical Ingredient
A substance or combination of substances used in a finished pharmaceutical product intended to furnish pharmacological activity or to otherwise have a direct effect in the diagnosis, cure,mitigation, treatment or prevention of disease.
Adult Treatment Panel
The guidelines that most Primary Care Provides utilize to treat lipids.
Adverse Drug Reaction
An expression that describes harm associated with the use of given medications at a normal dosage during normal use.
The FDA uses 50 committees and panels to obtain independent expert advice on scientific, technical and policy matters.
Affordable Care Act
Also known as Obamacare
American Association of Clinical Endocrinologists
A professional organization devoted to the field of clinical endocrinology.
American College of Physicians
The American College of Physicians is a national organization of internal medicine physicians —specialists who apply scientific knowledge and clinical expertise to the diagnosis, treatment, and compassionate care of adults across the spectrum from health to complex illness.
American Heart Association
The American Heart Association is a non-profit organization in the United States that fosters appropriate cardiac care in an effort to reduce disability and deaths caused by cardiovascular disease and stroke. It is headquartered in Dallas, Texas.
American Medical Association
The American Medical Association, founded in 1847 and incorporated in 1897, is the largest association of physicians—both MDs and DOs—and medical students in the United States.
Reducing triglyceride levels in patients with high triglycerides without inclreasing LDL-C levels in patients on background statin therapy.
Primary proteins known for carrying cholesterol to tissues
A polyunsaturated fatty acid present in animal fats.
AstraZeneca plc is a British-Swedish multinational pharmaceutical and biologics company headquartered in London, United Kingdom. It is the world's seventh-largest pharmaceutical company measured by 2009 prescription drug sales and has operations in over 100 countries.
Formation of atheromatous deposits, especially on the innermost layer of arterial walls.
Atherosclerotic Cardiovascular Disease
Hardening of the arteries.
Atherosclerotic Heart Disease
Hardening of the arteries.
The most common heart rhythm disorder. Often associated with palpatations, fainting, chest pain or congestive heart failure.
Having to do with an atrium and can rever to the left antriventricular opening, atrioventricular fistula or atrioventricular node.
The pressure exerted by circulating blood upon the walls of blood vessels.
Blue Cross and Blue Shield Association Health Insurance
One of the major health insurers in the United States.
A class of diseases that involve the heart, the blood vessels or both.
An incident which may cause damage to the heart.
Center for Drug Evaluation and Research
Part of the FDA, the CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
Centers for Disease Control and Prevention
The CDC is the national public health institute of the United States. The CDC is a federal agency under HHS and is headquartered in Atlanta.
A formal document that requests a government agency amend or retain the policy of concern to the petitioner.
Code of Federal Regulations
the codification of the general and permanent rules and regulations published in the Federal Register by departments and agencies of the federal government.
Comprehensive Medical Plan/Health Maintenance Organization
Complete coverage for hospital and physician charges subject to deductables and co-insurance. When obtained through an HMO services are obtained through a network of providers.
Congressional Budget Office
The Congressional Budget Office is a federal agency within the legislative branch of the United States government that provides economic data to Congress. The CBO was created as a nonpartisan agency by the Congressional Budget and Impoundment Control Act of 1974.
Coronary Artery Disease
Refers to the blockage of the small arteries that supply the heart muscle
A protein found in the blood, the levels of which rise in response to inflammation. It is an acute-phase protein.
Department of Health and Human Services
The United States government's principal agency for protecting the health of all Americans and providing essential human services.
Department of Justice
The United States Department of Justice (DOJ), also known as the Justice Department, is the U.S. federal executive department responsible for the enforcement of the law and administration of justice,
A rare form of diabetes caused by a deficiency of the pituitary hormone vasopressin, which regulates kidney function
The most common form of diabetes, caused by a deficiency of the pancreatic hormone insulin, which results in a failure to metabolize sugars and starch. Sugars accumulate in the blood and urine, and the byproducts of alternative fat metabolism disturb the acid–base balance of the blood, causing a risk of convulsions and coma.
A potentially life-threatening complication in patients with diabetes mellitus. It happens predominantly in those with type 1 diabetes, but it can occur in those with type 2 diabetes under certain circumstances
One of the Omega-3 fatty acids
A blind or blinded experiment is a test or experiment in which information about the test that might lead to bias in the results is concealed from the tester, the subject, or both until after the test.
Refers to the abnormal amount of lipids (i.e. LDL, VLDL, HDL, TG) in the blood.
An effective dose in pharmacology is the dose or amount of drug that produces a therapeutic response or desired effect in some fraction of the subjects taking it. The "median effective dose" is the dose that produces a quantal effect in 50% of the population that takes it.
Also known as icosapentaenoic acid. It is an omega-3 fatty acid.
Ratio of EPA to Arachidonic Acid. Considered to be a marker of inflammation. When the EPA/AA ratio is high, the effect tends to be anti-inflammatory and when low, then inflammatory in nature.
A daily publication of the US federal government that issues proposed and final administrative regulations of federal agencies.
Federal Trade Commission
An independent agency of the United States government, established in 1914 by the Federal Trade Commission Act. Its principal mission is the promotion of consumer protection and the elimination and prevention of anti-competitive business practices, such as coercive monopoly.
Fee For Service
A payment model where services are unbundled and paid for separately. In health care, it gives an incentife for physicians to provide more treatments because payment is dependant on the quantity and not the quality of care.
Food and Drug Administration
A component of the Department of Health and Human Services, the FDA is charged with ensuring that food is safe, pure, and wholesome; human and animal drugs, biological products, and medical devices are safe and effective; and electronic products that emit radiation are safe.
Freedom of Information Act
A federal freedom of information law allows for the full or partial disclosure of previously unreleased informatino and documents controlled by the USG.
The chief legal officer of a department or agency
Generally recognized as safe
Generally recognized as safe is an American Food and Drug Administration 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 food additive tolerance requirements.
Generally recognized as safe and Effective
A drug must satisfy 3 criteria: 1.) must have been subjected to adequate and well-controlled clinical investtigations that establish the product safe and effective; 2.) investigations must have been published in scientific literature available to qualified experts; 3.) experts must generally agree based on those studies that the product is safe and effective for its intended uses.
Glaxo Smith Kline
GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London,
Government Accountability Office
Investigative arm of Congress charged with examining matters relating to the receipt and payment of public funds.
Health Maintenance Organization
An organization that provides or arranges for managed care for health insurance.
An individual or institution that provides preventative, curative, promotional or rehabilitative health care services in a systematic way.
High Blood Pressure
A common disorder in which blood pressure remains abnormally high (a reading of 140/90 mm Hg or greater)
High sensitivity C-reactive protein
Considered to be a particle that is protective from Coronary Artery Disease.
Abbreviation for history - used in medical records.
Treatment of HDL to Reduce the Incidence of Vascular Events
Hypertension, also referred to as high blood pressure, is a condition in which the arteries have persistently elevated blood pressure.
Refers to the condition with very high levels of triglycerides in the blood (TG > 500 mg/dL)
Integrated Summary of Safety and Effectiveness
The combining of data in integrated summaries helps to address safety and efficacy concerns that are difficult to address using the data from individual trials.
Japan Eicosapentaenoic Acid (EPA) Lipid Intervention Study
Non-traditional” blood protein associated with higher risk of heart attack and stroke.
Lipoprotein-Associated Phospholipase A2
Prescription Omega-3 Fatty Acid approved for the treatment of hypertriglyceridemia (TG>500).
This particle is considered to be the most atherogenic.
Major Adverse Cardiac Event
Major adverse cardiac events (MACE) are referred to as unsuspected heart attacks that include death, myocardial infarction and target lesion revascularization.
Manual of Policy and Procedures
CDER's Manual of Policies and Procedures are federal directives and documentation of internal policies and procedures. MAPPs are required by law, and made available to the public to make CDER a more transparent organization.
The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of Vascepa in patients with fasting triglyceride levels greater than or equal to 500 mg/dl. Patients in this trial are characterized as having very high triglyceride levels according to the National Cholesterol Education Program Adult Treatment Panel III treatment guidelines.
Maximum Daily Dose
Recommended dose varies with body mass and indication.
Hyperlipidemia characterized by low levels of high-density lipoprotein cholesterol and elevated levels of triglycerides, with or without elevated levels of LDL-C.
The medical term for an event commonly known as a heart attack.
National Institutes of Health
A biomedical research facility located in Bethesda, MD. Under DHHS, it is the primary agency of the USG responsible for biomedical and health-related research.
New Chemical Entity
A drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug and Cosmetic Act. Provides additional protection from generics.
New Drug Application
The vehicle through which drug sponsors propose the FDA approve a new drug for sale and marketing. Goals of the NDA are to provide information to establish the following: 1.) is it safe and effective in its proposed use when directed? And do the benefits outweigh the risk; 2.) Is the package labeling appropriate and what should it contain; 3.) Are the controls used to maintain the quality adequate to preserve the drugs identity, strength, quality and purity?
New Molecular Entity
These products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients.
Total cholesterol minus HDL cholesterol
Office of Management and Budget
OMB assists the President in overseeing the preparation of the Federal budget and in supervising its administration in Federal agencies. The OMB also oversees and coordinates the Administration's procurement, financial management, information, and regulatory policies.
Office of the General Counsel
HHS lead counsel
Office of the Inspector General
The Office of the Inspector General's mission is to detect and deter waste, fraud, abuse, and misconduct in USG programs and personnel, and to promote economy and efficiency in those programs. Many USG agencies to include HHS and DOJ, maintain their own OIG.
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
Pfizer, Inc. is an American multinational pharmaceutical corporation headquartered in New York City, and with its research headquarters in Groton, Connecticut, United States. It is one of the world's largest pharmaceutical companies by revenues.
Polyunsaturated Fatty Acid
Polyunsaturated fatty acids (PUFAs) are fatty acids that contain more than one double bond in their backbone. EPA is a polyunsaturated fatty acid.
Prescription Drug User Fee Act
The PDUFA was a law passed by the United States Congress in 1992 which allowed the FDA to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
Primary Care Provider
A primary care provider is a health care practitioner who sees people that have common medical problems. This person is usually a doctor, but may be a physician assistant or a nurse practitioner.
Public Affairs Office
Public Affairs Office is a term for the formal officewhose purpose is to deal with the media and community issues.
Reduction of Cardiovascular Events with EPA - Intervention Trial
The REDUCE-IT study is a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study taking place at over 400 clinical sites in 11 countries to evaluate the effectiveness and safety of Vascepa® (icosapent ethyl) capsules, as an adjunct to optimized statin therapy, in reducing the incidence of first major cardiovascular events in a patient population at high risk for such events. The control arm of the study consists of patients on optimized statin therapy plus placebo. The active arm of the study consists of patients on optimized statin therapy plus Vascepa 4g/day. The high-risk patient population in REDUCE-IT has both a mean and median baseline triglyceride (TG) level over 200 mg/dL, a level substantially above those from recently conducted outcomes trials of other prescription lipid modifying therapies.
Request for Application
Request for Designation
By submitting a "Request for Designation" (RFD), a company may obtain a formal agency determination of a combination product’s primary mode of action and of assignment of the lead agency center for the product’s premarket review and regulation, or of the agency component that will have jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. The agency will make its jurisdictional determination within 60 days of filing the RFD.
Safety and Effectiveness
Certain drugs that do not require prior approval from the FDA in order to enter the United States marketplace because they are generally recognized as safe and effective by medical professionals.
Securities and Exchange Commission
The U.S. Securities and Exchange Commission (SEC) is an agency of the United States federal government. It holds primary responsibility for enforcing the federal securities laws and regulating the securities industry, the nation's stock and options exchanges, and other electronic securities markets in the United States. The SEC consists of five Commissioners appointed by the President of the United States, with the advice and consent of the US Senate. Their terms last five years, and are staggered so that one Commissioner's term ends on June 5 of each year. To ensure that the SEC remains non-partisan, no more than three Commissioners may belong to the same political party.
Special Protocol Assessment
An SPA is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.
Supplemental New Drug Application
Application submitted for an already approved NDA for any changes in packaging, labeling, dosages, ingredients or new indications.
The date by which an action will be completed.
HPS2-THRIVE involved over 25,000 men and women aged at least 50 with a history of heart attack, stroke or peripheral arterial disease. All study participants were given simvastatin and, if necessary, ezetimibe to ensure good control of LDL cholesterol. In addition, they were randomly allocated to receive extended release niacin/laropiprant or matching placebo tablets daily for about 4 years. The primary objective of the study was to see whether fewer participants given extended release niacin/laropiprant have heart attacks, strokes, revascularization procedures or die from coronary heart disease than do those in the placebo arm. results were presented at the American College of Cardiology meeting, San Francisco. HPS2-THRIVE concluded that adding ER niacin/laropiprant to current standard treatment did not produce worthwhile reductions in the risk of heart attacks, strokes and operations to open blocked arteries. The study also found that using ER niacin/laropiprant did cause side-effects.
Tier 1 Drug
Primarily made up of generic drugs. Contain the same active ingredients as their brand-name counterparts. May also include brand-name drugs that the plan has determined to be more effective, less costly or to have fewer side effects than similar medications. (Lowest Copay)
Tier 2 Drug
Made up of brand-name drugs for which generic equivalents are not available. These drugs have been selected by the plan based on review of the safety, effectiveness and cost. May also include generics that are more costly than their brand-name alternatives. (Middle Copay)
Tier 3 Drug
Drugs that the plan has not included in Tier 1 or Tier 2. (Highest Copay)
Tier 4 Drug
Specialty drugs used to treat complex, chronic conditions and may Require special handling and/or management. For plans that do not have 4 tiers, these drugs are found under tiers 1-3.
Title 21 CFR
21 Code of Federal Regulations refers to the regulations derived from the laws found in 21 USC
Title 21 USC
Title 21 United States Code codifies the laws governing the Food and Drug Administration.
The combined measurement of an individuals LDL (bad) cholesterol, HDL (good) cholesterol and triglycerides.
Fat in the blood
Type 2 Diabetes Mellitus
Diabetes mellitus type 2 is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency.
Type A meeting
A Type A meeting is a meeting needed to help an otherwise stalled product development program proceed. Types: Dispute resolution meetings; Meetings to discuss clinical holds in which a response to hold issues has been submitted, but the FDA and the sponsor or applicant agree that the development is stalled and a new path forward should be discussed; Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures as described in the guidance for industry Special Protocol Assessment. Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request.
United State Patent and Trademark Office
The U.S. Patent and Trademark Office is the agency responsible for granting U.S. patents and registering trademarks. It is a component of the US Dept of Commerce
United States Code
The Code of Laws of the United States. Is a compilation and codification of the general and permanent federal laws. At present - it contains 51 titles.
United States Public Health Service
The United States Public Health Service Commissioned Corps employs more than 6,000 public health professionals for the purpose of delivering public health promotion and disease prevention programs and advancing public health science. As one of seven uniformed services, the PHS Commissioned Corps fills public health leadership and service roles within federal government agencies and programs and includes officers drawn from many professions, including environmental and occupational health, medicine, nursing, dentistry, pharmacy, psychology, social work, hospital administration, health record administration, nutrition, engineering, science, veterinary, health information technology, and other health-related occupations.The mission of the U.S. Public Health Service Commissioned Corps is to protect, promote, and advance the health and safety of the United States. It is located in Rockville, MD.
The User Fee program allows FDA to collect fees to be used to support the surveillance of human and animal drugs, medical and mammography devices, color additives, exports, and tobacco products. The Division of User Fees is responsible for the overall management of the program.
Very Low Density Lipoproteins