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In many cases these responsibilities are shared with other federal agencies.
Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption Marihuana Tax Act Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency.
The Office of Criminal Investigations was established in 1991 to investigate criminal cases.The Office of Regulatory Affairs is considered the "eyes and ears" of the agency, conducting the vast majority of the FDA's work in the field.Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product.Inspection observations are documented on Form 483.On February 4, 2011, Canadian Prime Minister Stephen Harper and United States President Barack Obama issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness" Health Canada and the United States Food and Drug Administration (FDA) under the RCC mandate, undertook the "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter antihistamine ingredients (GC 2013-01-10)." The regulation of food and dietary supplements by the U. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA.