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