FDA

The Food and Drug Administration has proposed social media guidelines that would require drug companies using Twitter to include the risks of their products along with benefits.

The Food and Drug Administration (FDA) will develop e-cigarette policies that will protect public health, the head of the agency’s Center for Tobacco Products said Wednesday. The FDA is considering product standards in the areas of addiction, toxicity and product appeal.

Not all parts of the federal government agree on how to approach the issue of prescription painkiller abuse, according to the Associated Press.

The Food and Drug Administration’s decision to approve Zohydro ER (extended release), a pure form of the painkiller hydrocodone, has stirred opposition from many addiction medicine experts, public health officials and legislators. Join Together spoke with Dr. Richard Blondell, Vice Chair for Addiction Medicine in the State University of New York at Buffalo Department of Family Medicine, about the issue.

Manufacturers of e-cigarettes say they are pleased with the Food and Drug Administration’s proposed regulations of e-cigarettes, The Wall Street Journal reports. Consumer groups said the rules don’t go far enough, according to USA Today.

The Food and Drug Administration announced new rules on Thursday that would allow the agency to regulate e-cigarettes, The New York Times reports. The proposed rules would ban the sale of e-cigarettes, cigars and pipe tobacco to anyone under age 18.

An advisory panel of the Food and Drug Administration voted Tuesday against approving a combination morphine-oxycodone painkiller, NPR reports. The drug, Moxduo, would be the first medication to combine both opioids in one capsule.

The Food and Drug Administration has approved a handheld device that delivers a single dose of the opioid overdose antidote naloxone, The New York Times reports.

Food and Drug Administration Commissioner Margaret Hamburg defended the agency’s decision to approve the pure hydrocodone drug Zohydro ER (extended release). At a Senate hearing, Hamburg said, “If appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy.”

Attorneys General from 42 U.S. states and territories are urging the U.S. Food and Drug Administration to require drug companies to ensure generic prescription opioids have abuse-deterrent features.

The attorneys general from 28 states are asking the Food and Drug Administration (FDA) to reassess its decision to approve Zohydro ER (extended release), a pure form of the painkiller hydrocodone. Earlier this month, four U.S. senators told the FDA Commissioner Margaret Hamburg they disagree with the agency’s decision to approve the drug.

Four U.S. senators told the Commissioner of the Food and Drug Administration they disagree with the agency’s decision to approve a pure version of the painkiller hydrocodone, Newsday reports.

Last June, I testified before a Reference Committee at the annual meeting of the American Medical Association, explaining a resolution that American Society of Addiction Medicine had brought forward to encourage the Food and Drug Administration to reschedule hydrocodone combination products from Schedule III to Schedule II. I expected there to be few others testifying. I wasn’t at all ready for the long line of individuals standing at the “con” microphone, ready to speak against the resolution, says Dr. Stuart Gitlow, ASAM President.

The government shutdown in late September and early October likely delayed the Food and Drug Administration’s ruling on e-cigarette regulation, according to Consumer Reports.

Scientists at the Food and Drug Administration have found an amphetamine-like compound in nine dietary supplements, USA Today reports. The compound, beta-methylphenethylamine, appears to have never been tested for safety on humans.

The attorneys general of 24 states are urging the Food and Drug Administration to ban the sale of menthol cigarettes, CSPnet.com reports.

The maker of the dietary supplement OxyElite Pro is recalling some of its products, which have been linked to an outbreak of liver illnesses, the Food and Drug Administration said Saturday.

A number of states are making their own decisions about regulating e-cigarettes, as they await the Food and Drug Administration’s rules about the devices. Four states have included e-cigarettes in indoor smoking bans, and more are considering following suit.

The Food and Drug Administration on Friday approved the first pure hydrocodone drug in the United States. The drug, Zohydro ER (extended release), was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs.

Business and patient groups waged a costly lobbying campaign against tighter prescribing regulations for hydrocodone products for many years, according to The New York Times. Last week, the Food and Drug Administration recommended tighter restrictions for products containing hydrocodone and other painkillers such as acetaminophen or aspirin.

The Food and Drug Administration has recommended tighter restrictions for products containing hydrocodone and other painkillers such as acetaminophen or aspirin. These combination products include Vicodin and Lortab.

The Attorneys General of 41 states asked the Food and Drug Administration to issue regulations for e-cigarettes by the end of October. They said they want to ensure e-cigarette companies do not continue to sell or advertise to minors.

The U.S. Food and Drug Administration and the National Institutes of Health will award up to $53 million this fiscal year to create a tobacco research program. Funding over five years could reach $273 million, Reuters reports.

The U.S. Food and Drug Administration has announced safety labeling changes for extended-release and long-acting opioid painkillers. The new labels will call attention to the dangers of abuse and possible death, Reuters reports.

The impact of menthol cigarettes on young smokers is alarming, particularly when one considers the health consequences of a lifetime of smoking, says David Dobbins of the American Legacy Foundation.