FDA's ONP Reorganization Challenges Industry To Prioritize OTCs
This article was originally published in The Tan Sheet
FDA says OTC drug oversight remains important even as the Office of Nonprescription Products loses star billing within the Office of New Drugs, but the change could challenge firms to convince the agency to prioritize regulation of their products
You may also be interested in...
The FDA Office of Nonprescription Products' capacity to be part of a larger unit was a factor in reorganizing ONP into an office that also includes medical imaging oversight, drug center executive John Jenkins says
Oncology Drug Reviews To Be Restructured As Office Shifts Away From Divisions Organized Around Molecule Size
FDA's Office of Oncology Drug Products is undergoing a reorganization aimed at making its structure more similar to the rest of the review offices in the Center for Drug Evaluation and Research
This spring, FDA's Division of OTC Drug Products will be elevated to full office status within the Center for Drug Evaluation & Research. OTC Division Director Charles Ganley, MD, sat down with "The Tan Sheet" on Dec. 17 to discuss the ramifications of the organizational change, as well as hot-button issues such as the current Rx-to-OTC switch environment, possible monograph system improvements and advisory committee reviews.