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Sibutramine, formerly sold under the brand name Meridia among others, is an appetite suppressant which has been discontinued in many countries. It works as a serotonin–norepinephrine reuptake inhibitor (SNRI) similar to certain antidepressants.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. [7] The FDA also conducts active surveillance of certain regulated products.
The Food and Drug Administration just granted over-the-counter sale marketing authorization for MED3000, a topical gel created to treat erectile dysfunction (ED). ... which can take time. But, you ...
Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
A 2010 study found the amount of chrysin was 0.10 mg/kg in honeydew honey, and 5.3 mg/kg in forest honeys. [10] A 2010 study found the amount of chrysin in propolis was as much as 28 g/L. [ 10 ] A 2013 study found the amount of chrysin in various mushrooms from the island of Lesvos, Greece, varied between 0.17 mg/kg in Lactarius deliciosus to 0 ...
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 ...
Clinical investigator fraud: An investigation by OCI and the Veterans Affairs (VA) Office of Inspector General resulted in the conviction of a VA physician who falsified documentation of a clinical drug study and recklessly enrolled patients who did not qualify under the study protocol. The physician's criminal negligence caused the death of ...