US FDA Recalibrates Office Of Generic Drugs
As Part Of Wider Structural Changes To CDER
As part of a wider overhaul of the FDA’s Center for Drug Evaluation and Research, the agency is reorganizing its Office of Generic Drugs, including adding a new Office of Safety and Clinical Evaluation within the OGD.
You may also be interested in...
The sixth annual report of the FDA’s Office of Generic Drugs covered a year dominated by the novel coronavirus pandemic – although first-time generic approvals and record levels of communication also featured prominently.
Following the announcement in February that South Korea had been chosen by the WHO as the location for a global biomanufacturing training hub, a video shared by the IGBA has shed more light on what can be expected from the initiative.
Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.