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September 13 – Generics Act of 1988 (Republic Act No. 6675) was signed by President Aquino in order to require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic name. [11]
t. e. The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to ...
Republic Act No. 9502 or the "Universally Accessible and Quality Medicines Act of 2008" is an act that aims to provide cheaper and better quality medicines to the Filipino people. It is an amendment of Republic Act No. 8293, or the "Intellectual Property Code of the Philippines", Republic Act No. 6675, or the "Generics Act of 1988", and ...
Although the average price of a generic prescription covered by Medicare Part D plans is $17 and has fallen since 2009, according to the Congressional Budget Office, 12% of Medicare beneficiaries ...
The Anti-Drug Abuse Act of 1988 ( Pub. L. 100–690, 102 Stat. 4181, enacted November 18, 1988, H.R. 5210) is a major law of the War on Drugs passed by the U.S. Congress which did several significant things: Created the policy goal of a drug-free America; Established the Office of National Drug Control Policy; [ 2] and.
Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients; whereas according to the U.S. Food and Drug Administration's Office of Generic Drugs, generic drugs are ...
For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the ...
The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs (BFAD / ˈ b iː f æ d /; 1982–2009), is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the "Food, Drugs and Devices, and Cosmetics Act", and subsequently reorganized by Republic Act No ...