Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate
Executive Summary
Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages.
You may also be interested in...
In Food Programs Restructuring, US FDA Has Designs On Clear Priorities, Chain Of Command
Following reviews prompted largely by formula supply crisis, FDA will move Center for Food Safety and Applied Nutrition and commissioner’s Office of Food Programs and Response to Human Foods Program headed by deputy commissioner. Office of Regulatory Affairs' structure also changing “to support the FDA organization as a whole,” says Commissioner Califf.
Drug GMP and CMC Updates In Brief: Guidance Advances on Several Fronts
The US FDA revised two drug good manufacturing practice inspection programs in its compliance manual to reflect certain ICH guidance documents, efforts to control nitrosamine impurities and the use of inspection alternatives for evaluating facilities. Plus more recent developments in GMP and CMC compliance.
Vid Desai On How US FDA’s Modernization Will Improve Inspections And Drug Reviews
FDA’s chief information officer talks to the Pink Sheet about why the agency relied on COVID data from foreign countries, and describes pilot projects to target inspections and manage warehouse data.