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The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was signed into law by United States President Ronald Reagan as part of a larger health bill on November 14, 1986.
In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information leaflet" (PIL) or "package leaflet". [3] Similar documents attached to the outside of a package are sometimes called outserts. [citation needed]
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
Whiplash, whose formal term is whiplash associated disorders (WAD), is a range of injuries to the neck caused by or related to a sudden distortion of the neck [1] associated with extension, [2] although the exact injury mechanisms remain unknown. The term "whiplash" is a colloquialism. "Cervical acceleration–deceleration" (CAD) describes the ...
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.
It authorizes the FDA to require a responsible person for a drug to conduct a post-approval study or clinical trial of the drug to assess a known serious risk or signals of a serious risk or to identify an unexpected serious risk, to require a postapproval study or clinical trial for an already approved drug only if the Secretary becomes aware ...
A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes. Acronyms (colloquial) FDAMA: Enacted by: the 105th United States Congress: Effective: November 21, 1997: Citations; Public law: 105-115: Statutes at Large ...
Head restraint in a Lincoln Town Car. Head restraints (also called headrests) are an automotive safety feature, attached or integrated into the top of each seat to limit the rearward movement of the adult occupant's head, relative to the torso, in a collision — to prevent or mitigate whiplash or injury to the cervical vertebrae.