When It Comes To Sponsor Meetings, FDA Is Getting A ‘D’
New ‘Type D’ meetings will be added as part of PDUFA VII, one of a spate of changes under the next version of the user fee program that will begin in October 2022.
You may also be interested in...
Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.
The Center for Drug Evaluation and Research’s policy guru must think about the future, along with the present, in her position as director of the Office of Regulatory Policy.
US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.