The U.S. Food and Drug Administration (FDA) declined to approve a new drug application for a second nasal spray version of the opioid overdose antidote naloxone, Medscape reports. The FDA approved a nasal spray version of naloxone last month.
The Food and Drug Administration on Tuesday ordered tobacco company R.J. Reynolds to stop selling four cigarette products. It is the first time the agency has ordered a major tobacco company to stop selling products, according to NPR.
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.
At a Food and Drug Administration hearing this week to consider whether the smokeless tobacco known as “snus” is less harmful than cigarettes, government scientists questioned a proposal to modify cancer warning language on the product’s packaging.
The Food and Drug Administration this week issued guidelines for drug manufacturers on developing opioid painkillers that are more difficult to abuse. The guidelines recommend the types of studies needed to prove drugs can deter abuse, The Wall Street Journal reports.
Although alcohol in powdered form has been around for decades – long before a 1976 patent for it was issued to the General Foods Corporation – the announcement of a new product tabbed for the market has pushed the topic back to the forefront.
Drugs to treat alcoholism would not have to lead to sobriety in order to be approved by the Food and Drug Administration, under a proposal by the agency. Instead, drug companies could gain approval for treatments if they prove patients using them no longer drink heavily.