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As Y-Sets [1] are the most common shaped sets, Y-Set is a name that is sometimes used to represent the family of connector sets (sometimes called Y-tubes). The majority of these infusion sets have a left and right hand line that deliver fluid and drugs (often via a valve) to a short common limb attached to the female fitting on the intravenous ...
In the United States, the Food and Drug Administration (FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car.
Oral administration of a liquid. In pharmacology and toxicology, a route of administration is the way by which a drug, fluid, poison, or other substance is taken into the body. [1] Routes of administration are generally classified by the location at which the substance is applied. Common examples include oral and intravenous administration ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.
Drug delivery is a concept heavily integrated with dosage form and route of administration, the latter sometimes being considered part of the definition. [9] While route of administration is often used interchangeably with drug delivery, the two are separate concepts.
The U.S. Food and Drug Administration (FDA) approved trastuzumab emtansine in February 2013, and granted the application for Kadcyla to Genentech. [18] The FDA granted the application for trastuzumab emtansine priority review and breakthrough therapy designations. [24] In 2013, trastuzumab emtansine was approved in the UK, [4] and the EU. [6]
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.