Food and Drug Administration in the context of "Vaccines and autism"

A monograph is generally a long-form work on one (usually scholarly) subject, or one aspect of a subject, typically created by a single author or artist (or, sometimes, by two or more authors). Traditionally it is in written form and published as a book, but it may be an artwork, audiovisual work, or exhibition made up of visual artworks. In library cataloguing, the word has a specific and broader meaning, while in the United States, the Food and Drug Administration uses the term to mean a set of published standards as well as various guidelines.

A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous jurisdiction over some area of human activity in a licensing and regulating capacity. Examples of responsibilities include strengthening safety and standards, and/or to protect consumers in markets where there is a lack of effective competition. Examples of regulatory agencies that enforce standards include the Food and Drug Administration in the United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom; and, in the case of economic regulation, the Office of Gas and Electricity Markets and the Telecom Regulatory Authority in India.

Probiotics are live microorganisms in that are intended to support or improve the health and wellbeing of a host organism. They are commonly used in both humans and animals. Although the term refers to the microorganisms themselves, probiotics can be consumed through a range of products including yogurt, cheese, certain fermented foods (such as nattō), as well as capsules containing a single strain or a defined mixture of strains.

Probiotics are regarded as generally recognised as safe (GRAS) by the U.S. Food and Drug Administration (FDA), which supports their safety when used as intended, although this designation does not establish their effectiveness or specific health benefits. Many claimed health benefits, such as treating eczema or curing vaginal infections, lack substantial scientific support.

A slogan is a memorable motto or phrase used in a clan or a political, commercial, religious, or other context as a repetitive expression of an idea or purpose, with the goal of persuading members of the public or a more defined target group. The Oxford Dictionary of English defines a slogan as "a short and striking or memorable phrase used in advertising". A slogan usually has the attributes of being memorable, very concise and appealing to the audience.

The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications. Medications are then administered to (or self-administered by) patients for curing or preventing disease or for alleviating symptoms of illness or injury.

Generic drugs are typically not protected by patents, whereas branded drugs are covered by patents. The industry's various subdivisions include distinct areas, such as manufacturing biologics and total synthesis. The industry is subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs.

COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research (506 total candidates in April 2021), with 419 potential COVID-19 drugs in clinical trials, as of April 2021.

As early as March 2020, the World Health Organization (WHO), European Medicines Agency (EMA), US Food and Drug Administration (FDA), and the Chinese government and drug manufacturers were coordinating with academic and industry researchers to speed development of vaccines, antiviral drugs, and post-infection therapies. The International Clinical Trials Registry Platform of the WHO recorded 536 clinical studies to develop post-infection therapies for COVID-19 infections, with numerous established antiviral compounds for treating other infections under clinical research to be repurposed.

In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis is the assessment that a particular medical condition is present while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits.

In the US, indications for prescription drugs are approved by the Food and Drug Administration (FDA). Indications are included in the Indications and Usage section of the Prescribing Information. The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s). The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof, for which the drug is approved, as well as whether the drug is indicated for the treatment, prevention, mitigation, cure, relief, or diagnosis of that disease or condition. Additionally, the Indications and Usage section should contain the approved age groups as well as other information necessary to describe appropriate use (for example, identifying the indicated patient/disease subgroups, stating if adjunctive therapy is required).

A drug class is a group of medications and other compounds that share similar chemical structures, act through the same mechanism of action (i.e., binding to the same biological target), have similar modes of action, and/or are used to treat similar diseases. The FDA has long worked to classify and license new medications. Its Drug Evaluation and Research Center categorizes these medications based on both their chemical and therapeutic classes.

In several major drug classification systems, these four types of classifications are organized into a hierarchy. For example, fibrates are a chemical class of drugs (amphipathic carboxylic acids) that share the same mechanism of action (PPAR agonist), the same mode of action (reducing blood triglyceride levels), and are used to prevent and treat the same disease (atherosclerosis). However, not all PPAR agonists are fibrates, not all triglyceride-lowering agents are PPAR agonists, and not all drugs used to treat atherosclerosis lower triglycerides.A drug class is typically defined by a prototype drug, the most important, and typically the first developed drug within the class, used as a reference for comparison.

The 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 Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was 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 influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was used to dissolve the drug and make a liquid form. It replaced the earlier Pure Food and Drug Act of 1906.

On December 31, 2019, China announced the discovery of a cluster of pneumonia cases in Wuhan. The first American case of COVID-19 was reported on January 20, and Health and Human Services Secretary Alex Azar declared a public health emergency on January 31. Restrictions were placed on flights arriving from China, but the initial U.S. response to the COVID-19 pandemic was otherwise slow in terms of preparing the healthcare system, stopping other travel, and testing. The first known American deaths occurred in February and in late February President Donald Trump proposed allocating $2.5 billion to fight the outbreak. Instead, Congress approved $8.3 billion and Trump signed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 on March 6. Trump declared a national emergency on March 13. The government also purchased large quantities of medical equipment, invoking the Defense Production Act of 1950 to assist. By mid-April, disaster declarations were made by all states and territories as they all had increasing cases. A second wave of infections began in June, following relaxed restrictions in several states, leading to daily cases surpassing 60,000. By mid-October, a third surge of cases began; there were over 200,000 new daily cases during parts of December 2020 and January 2021.

COVID-19 vaccines became available in December 2020, under emergency use, beginning the national vaccination program, with the first vaccine officially approved by the Food and Drug Administration (FDA) on August 23, 2021. Studies have shown them to be highly protective against severe illness, hospitalization, and death. In comparison with fully vaccinated people, the CDC found that those who were unvaccinated were from 5 to nearly 30 times more likely to become either infected or hospitalized. There nonetheless was some vaccine hesitancy for various reasons, although side effects were rare. There were also numerous reports that unvaccinated COVID-19 patients strained the capacity of hospitals throughout the country, forcing many to turn away patients with life-threatening diseases.