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Food And Drug Administration Amendments Act Of 2007
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate. The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program, amongst other items. Title I: Prescription Drug User Fee Amendments of 2007 Title I amends the Federal Food, Drug, and Cosmetic Act to include post-marketing safety activities in the review of drug application. This included developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety probl ... [...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 safety of food, drugs, medical devices, and cosmetics. 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 use ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse e ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Antibiotics
An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting bacterial infections, and antibiotic medications are widely used in the treatment and prevention of such infections. They may either kill or inhibit the growth of bacteria. A limited number of antibiotics also possess antiprotozoal activity. Antibiotics are not effective against viruses such as the common cold or influenza; drugs which inhibit viruses are termed antiviral drugs or antivirals rather than antibiotics. Sometimes, the term ''antibiotic''—literally "opposing life", from the Greek roots ἀντι ''anti'', "against" and βίος ''bios'', "life"—is broadly used to refer to any substance used against microbes, but in the usual medical usage, antibiotics (such as penicillin) are those produced naturally (by one microorganism fighting another), whereas non-antibiotic antibacterials (such as sulfonamides and an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Safety Oversight Board
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalation, injection, smoking, ingestion, absorption via a patch on the skin, suppository, or dissolution under the tongue. In pharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect. A pharmaceutical drug, also called a medication or medicine, is a chemical substance used to treat, cure, prevent, or diagnose a disease or to promote well-being. Traditionally drugs were obtained through extraction from medicinal plants, but more recently also by organic synthesis. Pharmaceutical drugs may be used for a limited duration, or on a regular basis for chronic disorders. Pharmaceutical drugs are often classified into drug classes—groups of re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Public Health Service Act
The Public Health Service Act is a United States federal law enacted in 1944. The full act is codified in Title 42 of the United States Code (The Public Health and Welfare), Chapter 6A ( Public Health Service). Contents The act clearly established the federal government's quarantine authority for the first time. It gave the United States Public Health Service responsibility for preventing the introduction, transmission and spread of communicable diseases from foreign countries into the United States. The Public Health Service Act granted the original authority for scientists and special consultants to be appointed "without regard to the civil-service laws", known as a Title 42 appointment. During COVID-19 pandemic, section has been used for Title 42 expulsion. Amendments It has since been amended many times. Some of these amendments are: * Family Planning Services and Population Research Act of 1970 , which established Title X of the Public Health Service Act, dedicated ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nonprofit
A nonprofit organization (NPO) or non-profit organisation, also known as a non-business entity, not-for-profit organization, or nonprofit institution, is a legal entity organized and operated for a collective, public or social benefit, in contrast with an entity that operates as a business aiming to generate a profit for its owners. A nonprofit is subject to the non-distribution constraint: any revenues that exceed expenses must be committed to the organization's purpose, not taken by private parties. An array of organizations are nonprofit, including some political organizations, schools, business associations, churches, social clubs, and consumer cooperatives. Nonprofit entities may seek approval from governments to be tax-exempt, and some may also qualify to receive tax-deductible contributions, but an entity may incorporate as a nonprofit entity without securing tax-exempt status. Key aspects of nonprofits are accountability, trustworthiness, honesty, and openness to ever ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Reagan-Udall Foundation
The Reagan-Udall Foundation for the Food and Drug Administration is a private nonprofit (501c3) organization, created to support the mission of the U.S. Food and Drug Administration (FDA) to help equip FDA staff with the highest caliber, regulatory science and technology in order to enhance the safety and effectiveness of FDA regulated products. Although it was mandated by Congress in the Food and Drug Administration Amendments Act of 2007 to help support and promote FDA's regulatory science priorities, it is independent of the agency, with its own Board of Directors, staff and research agenda. The Reagan-Udall Foundation creates public–private partnerships to advance research in regulatory science, enhance medical decision making, and promote innovation. It also advances regulatory science through fellowships and other training programs, both for private scientists and for FDA staff. Activities The Reagan-Udall Foundation is collaborating with FDA in several high-prior ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pediatric Trials Network
The Pediatric Trials Network (PTN) is a consortium of clinical research sites located around the United States that are cooperating in the design and conduct of clinical trials to improve health care for young patients. The network is sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The work of the PTN addresses a critical lack of information regarding the impact of therapeutic agents on infants and children. Developing organs and changes in metabolism throughout infancy and childhood affect how drugs are processed by immature or maturing bodies; thus, age-dependent adjustments in doses are required to ensure that such therapies are used safely and effectively. Unfortunately, only a small percentage of drugs and devices approved by the Food and Drug Administration (FDA) have actually been studied in children and are labeled for pediatric use. Pediatricians, consequently, are often forced to prescribe medical therapies "off-la ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Best Pharmaceuticals For Children Act
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate. The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program, amongst other items. Title I: Prescription Drug User Fee Amendments of 2007 Title I amends the Federal Food, Drug, and Cosmetic Act to include post-marketing safety activities in the review of drug application. This included developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety probl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Short Title
In certain jurisdictions, including the United Kingdom and other Westminster-influenced jurisdictions (such as Canada or Australia), as well as the United States and the Philippines, primary legislation has both a short title and a long title. The long title (properly, the title in some jurisdictions) is the formal title appearing at the head of a statute (such as an act of Parliament or of Congress) or other legislative instrument. The long title is intended to provide a summarised description of the purpose or scope of the instrument. Like other descriptive components of an act (such as the preamble, section headings, side notes, and short title), the long title seldom affects the operative provisions of an act, except where the operative provisions are unclear or ambiguous and the long title provides a clear statement of the legislature's intention. The short title is the formal name by which legislation may by law be cited. It contrasts with the long title which, while usua ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Drugs
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug research and development. In the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to encourage development of drugs which would otherwise lack sufficient profit motive to attract corporate research budgets and personnel. Definition According to the US Food and Drug Administration (FDA), an orphan drug is defined as one "intended for ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
