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The U.S. Food and Drug Administration (FDA) has released a final guidance detailing new and current programs that convey drug safety information to the public as part of a larger drug safety initiative, the agency announced.
Pfizer recently updated physician labeling in the European Union (EU) for antibacterial agent Zyvox to reflect safety restrictions for use in patients with serious catheter-related bloodstream infections, the company told DID.
Sponsors with data monitoring committees (DMCs) can take a number of steps to reduce potential liability, according to an attorney expert in the field.
The FDA is reviewing the safety and efficacy of cough and cold medications for children to decide whether the methods used to determine dosages were sufficient, the agency announced.
Research sites must have consistent processes for billing Medicare to stay in compliance with the law, Kelly Willenberg, director of clinical research financial compliance at Vanderbilt University Medical Center's Department of Finance, said.
Recommendations in the latest installment of the Prescription Drug User Fee Act (PDUFA) seek to bulk up the premarket drug approval process, stabilize financing and expedite drug development, FDA officials said at a public hearing last week.
The FDA has signed a memorandum of understanding (MOU) with the Department of Veterans Affairs (VA) in which the two bodies will share information and expertise related to the review and use of devices, drugs and biologics.
While recent Centers for Disease Control and Prevention (CDC) data show an increase in the number of adolescent suicides since black box warnings were added to some types of antidepressants, there may not be enough data to link the two, a government source says.