Expertise: Consulting 206 results
Consulting
Early FDA Feedback with Type D Meetings
What is the Type D meeting? The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. This new meeting is designed to make it easier and...
During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance,...
Consulting
William Salminen, Ph.D., DABT, PMP
Premier Research's regulatory strategists specializing in the US FDA’s 505(b)(2) approval pathway are often asked how a sponsor can recover from a pre-IND meeting that doesn’t go as planned. While we firmly believe that setbacks can be turned into opportunities...
Consulting
Greg Meyer, RAC, CQA
Consulting
Olu Aloba, Ph.D.
Clinical Development
Clint Dart, M.S.
The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. With many steps in between, each as important as the next, multiple factors regarding development strategy...
All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers. Periodically, the FDA updates these forms to...