Recently in College of Pharmacy Category
The U.S. Food and Drug Administration (FDA) has extended its review of the obesity drug Qnexa for three more months. The new target date provides the FDA additional time to review a new drug safety plan submitted by the company who manufactures Qnexa.
But according to the Associated Press, the drug may face an uphill battle for approval:
"The FDA has rejected three experimental drugs for obesity in the last three years, including Qnexa, raising questions about whether any new weight loss drugs can win approval. The agency has not approved a new prescription diet pill since 1999."
So what exactly does it take for a drug to receive the FDA's approval?
"Once a drug is created by a company, there is still a long process before it is sent to the FDA," said Schondelmeyer. "It must go through three phases of rigorous trials and testing, often lasting five to ten years total."
After three phases of clinical trials are complete and confirm the drug's safety and success, the drug is submitted to the FDA Expert Advisory panel, which makes a recommendation to the FDA.
If recommended by the panel, the drug is then reviewed by internal divisions of the FDA, each reviewing for their area of expertise. Finally, the drug is brought to the FDA Commissioner's Office for the final approval.
"The FDA approval process is designed to ensure patients and consumers have access to the safest drugs available," said Schondelmeyer. "It's a process designed with safety in mind."
Issues with drug manufacturing has many causes and has led to large prescription drug shortages. Stephen Schondelmeyer, College of Pharmacy, talks about how there is no single cause and no single solution to the drug shortage problem.
A new drug could make it easier for first responders to treat cyanide poisoning in emergency situations. Steve Patterson and Herbert Nagasawa, Center for Drug Design, talk about how their drug is easier to administer and would work faster than others out now.
Read on MN Daily
The U of M College of Veterinary Medicine and College of Pharmacy, Mayo Clinic, University of Pennsylvania and others are teaming up to study new ways to predict and control epileptic seizures in dogs and people.
Read on Hometown Source
Financial conflicts-of-interest has been a growing issue in medicine. Leigh Turner, College of Pharmacy and Center for Bioethics, explains that bioethicists have to write about ethical issues related to medicine, health care, and biotechnology for the good of the industry.
Read on MinnPost
Student volunteers from the School of Public Health, Medical School, School of Nursing and College of Pharmacy use an inter-professional approach, combining their skills, to find the best care for patients at a free, student-run clinic in the Phillips Neighborhood of Minneapolis.
Read on Twin Cities Daily Planet
Prominent bioethicist Glenn McGee will soon be taking a job with a for-profit stem-cell company. Leigh Turner, College of Pharmacy and Center for Bioethics, wrote about the potential conflict of interest Dr. McGee got himself into.
Read on Inside Higher Ed
Many people now are choosing to take part in medical tourism in order to find the best care. Leigh Turner, College of Pharmacy, School of Public Health and Center for Bioethics, explains that people need to do their research to find the best deal.
Read on The Globe and Mail
Researchers from the U of M and Mayo Clinic are another step closer to developing a drug to combat fungal infections. Michael Walters, College of Pharmacy, is conducting research on new drugs because current drugs are becoming compromised as fungi become resistant to them.
Drug shortages are a growing problem in many hospitals around the country. Stephen Schondelmeyer, College of Pharmacy, explains that there is no simple solution because each drug shortage has its own story.
Read on Pioneer Press
U.S. Sen. Amy Klobuchar is taking on the pharmaceutical industry over the problem of drug shortages. Stephen Schondelmeyer, College of Pharmacy, talks about the different aspects pay-for-delay tactics that pharmaceutical companies use.
Read on Star Tribune
President Eric Kaler is strongly considering an external review of the Academic Health Center. Michael Oakes, School of Public Health, and Colin Campbell, College of Pharmacy, discuss the outcomes of the initial internal review.
Read on MN Daily
Health reform is one of many topics at this year's Midyear Clinical Meeting and Exhibition. Brian Isetts, College of Pharmacy, explains that safe and effective use of medications is so important to everything that underscores health reform.
Read on Pharmacy Practice News
Synthetic drug makers are working like modern-day moonshiners to cash in on the booming market. David Ferguson, College of Pharmacy, discusses the legality and dangers of homemade drugs.
Tobacco smoke has devastating effects on smokers and non-smokers alike, the worst being infants. Stephen Hecht, Medical School, College of Pharmacy and Masonic Cancer Center, discusses how second-hand smoke can lead to asthma and bronchitis in children.
Designer drugs going under the product name "Black Rooster" were being sold in a local convenience store in Heflin, Alabama. David Ferguson, College of Pharmacy, talks about how people really have no idea what they are ingesting when they take designer drugs.
The Gophers football coach is recovering after a routine, but very public, seizure. Ilo Leppick, College of Pharmacy, discusses the lasting effects of seizures and the recovery process in adults.
Synthetic drugs are widely sold as bath salts and incense. But lab tests reveal substances that can kill. David Ferguson, College of Pharmacy, provides expertise about the dangerous effects fake synthetic drugs cause.