The Food and Drug Administration issued a rule this week that allows the agency to destroy poor-quality or fake drugs valued at $2,500 or less that are refused admission into the United States. Until now, only counterfeit or poor quality food or medical devices could be destroyed.
An advisory panel to the Food and Drug Administration (FDA) has voted in favor of approving a new opioid painkiller made by Collegium Pharmaceuticals. The panel’s unanimous vote was contrary to a recommendation by FDA staff, according to Reuters.
The Food and Drug Administration’s decision last month to approve the opioid painkiller OxyContin for children as young as 11 has been welcomed by some pediatricians and pain specialists, The Washington Post reports. Some critics, however, say the decision could lead to increased abuse of the drug.
New regulations for e-cigarettes are likely to have a large impact on the industry, experts say. The rules could force many small e-cigarette businesses to close, while benefitting large tobacco companies.
The three largest U.S. tobacco companies this week announced they will drop their lawsuit against the Food and Drug Administration, after the agency said it would reconsider rules about the companies’ product labels.
The Food and Drug Administration this week denied a request from two subsidiaries of the tobacco company Reynolds American to change the warning label of smokeless tobacco products to indicate they are less risky than traditional cigarettes.
The American College of Physicians this week urged the Food and Drug Administration (FDA) to ban flavorings and television ads for e-cigarettes. The group joins many other medical organizations, including the American Medical Association and the American Heart Association, in calling on the FDA to regulate e-cigarettes.
The three largest tobacco companies are suing the Food and Drug Administration (FDA), claiming new guidelines issued by the agency infringe on their commercial speech. The new guidelines are designed to help manufacturers decide which new products require FDA review.
U.S. Senator Charles Schumer of New York is urging the Food and Drug Administration to ban over-the-counter dietary supplements that contain the stimulant beta-methylphenethylamine, or BMPEA. The stimulant, often marketed as a weight-loss aid, can lead to serious health problems, doctors say.