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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1] While the FDA generally determines violations through its own inspections, they can also issue one based on evidence from state personnel. [2] The FDA considers a warning letter informal and advisory.
Insurance is characterized as a business vested or affected with the public interest. [2] Thus, the business of insurance, although primarily a matter of private contract, is nevertheless of such concern to the public as a whole that it is subject to governmental regulation to protect the public’s interests. [1]
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.
In the US, Good Manufacturing Practice (GMP) Regulations are based on the Code of Federal Regulations 21 CFR 210/211, and USP 1079. The US Drug Supply and Chain Security Act (DSCSA), was enacted by Congress on November 26, 2013 and outlines requirements to build electronic systems that identify and trace prescription drugs distributed in the US ...
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...
A Catholic nun with the Sisters of Charity Institute in Milan was among 25 people arrested early Thursday morning for a litany of mafia-related crimes, including aiding and abetting extortion ...
The McCarran–Ferguson Act, 15 U.S.C. §§ 1011-1015, is a United States federal law that exempts the business of insurance from most federal regulation, including federal antitrust laws to a limited extent. The 79th Congress passed the McCarran–Ferguson Act in 1945 after the Supreme Court ruled in United States v.