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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.
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 ]
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.
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.
4-Aminosalicylic acid, also known as para-aminosalicylic acid (PAS) and sold under the brand name Paser among others, is an antibiotic primarily used to treat tuberculosis. [2] Specifically it is used to treat active drug resistant tuberculosis together with other antituberculosis medications . [ 3 ]
Santé Canada Direction générale des opérations réglementaires et de l'application de la loi (DGORAL) 1999 Chinese Taipei: Food and Drug Administration (TFDA) 2013 Croatia: Agency for Medicinal Products and Medical Devices of Croatia Agencija za lijekove i medicinske proizvode (HALMED) 2016 Cyprus: Pharmaceutical Services (CyPHS) 2008 Czech ...
Spanish is the official language of Guatemala, and is spoken by 93% of the population. [1] Guatemalan Spanish is the local variant of the Spanish language.. Twenty-two Mayan languages are spoken, especially in rural areas, as well as two non-Mayan Amerindian languages: Xinca, an indigenous language, and Garifuna, an Arawakan language spoken on the Caribbean coast.