Search results
Results from the WOW.Com Content Network
Good documentation practice. Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various ...
Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems ...
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
US FDA classifies corrections to instructions for Abiomed's blood pumps as most serious. March 21, 2024 at 3:47 PM. (Reuters) - The U.S. health regulator on Thursday classified corrections...
Laser-Assisted in Situ Keratomileusis (LASIK), commonly referred to as laser eye surgery or laser vision correction, is a type of refractive surgery for the correction of myopia, hyperopia, and an actual cure for astigmatism, since it is in the cornea.
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).
Website. fda .gov. 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 ...
They are inspectional observations, and do not represent a final Agency determination regarding your compliance. A recipient of a 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires. [4]
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its ...
An Intraocular lens ( IOL) is a lens implanted in the eye usually as part of a treatment for cataracts or for correcting other vision problems such as short sightedness and long sightedness; a form of refractive surgery. If the natural lens is left in the eye, the IOL is known as phakic, otherwise it is a pseudophakic lens (or false lens).