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The Ministry of Public Health and Social Assistance (Spanish: Ministerio de Salud Pública y Asistencia Social or MSPAS) is a government ministry of Guatemala, headquartered in Zone 11 of Guatemala City.
In 2011, the American Medical Association recommended a uniform prior authorization form with real-time electronic processing. The proposed process would involve a physician ordering a medical service, their staff completing a standardized request form, and an electronic submission process with same-day approval or denial.
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
In 1990, as part of the Immigration Act of 1990 ("IMMACT"), P.L. 101–649, Congress established a procedure by which the Attorney General may provide temporary protected status to immigrants in the United States who are temporarily unable to safely return to their home country because of ongoing armed conflict, an environmental disaster, or other extraordinary and temporary conditions.
(Reuters) - Germany's BioNTech SE said in a regulatory filing on Monday the U.S. Food and Drug Administration has placed a partial clinical hold on an early-stage study of its experimental cancer ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
Among the categories of parole are port-of-entry parole, humanitarian parole, parole in place, removal-related parole, and advance parole (typically requested by persons inside the United States who need to travel outside the U.S. without abandoning status, such as applicants for LPR status, holders of and applicants for TPS, and individuals with other forms of parole).
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]