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The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs.
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
Marketing of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The pharmaceutical marketing plan incorporates the spending plans, channels, and thoughts which will take the drug association, and its items and administrations, forward in the current scene.
The safety and the effectiveness of prescription drugs in the US are regulated by the 1987 Prescription Drug Marketing Act (PDMA). The Food and Drug Administration (FDA) is charged with implementing the law.
Orphan Drug Act, PL 97–414 (January 4, 1983) Drug Price Competition and Patent Term Restoration Act of 1984, PL 98–417 (aka Hatch-Waxman) (September 24, 1984) Prescription Drug Marketing Act of 1987, PL 100–293 (August 18, 1988) Generic Animal Drug and Patent Term Restoration Act of 1988, PL 100–670 (November 16, 1988)
Drug Price Competition and Patent Term Restoration Act (1984) – Allows the FDA to approve generic versions of previously approved new drugs without requiring their sponsors to duplicate the costly human tests required for the original drugs. Prescription Drug Marketing Act (1988) – Allows selling, buying, trading, or offering to sell, buy ...
The Prescription Drug User Fee Act ... were lost each year due to delays in approval and marketing of drugs for cancer and ... granted 2 years later, in 1987. [5]
During his tenure, Young presided over several major agency events, including the Drug Price Competition and Patent Term Restoration Act (1984), passage of the Prescription Drug Marketing Act (1987), approval of the first drug to combat AIDS, zidovudine (AZT) (1987), development of the treatment use of Investigational New Drugs (IND) for the ...