Will Califf’s Attention To Foods Come At Expense Of US FDA’s Drugs Program?
FDA Commissioner Robert Califf says the medical product programs have received a lot of attention and now it’s the food program’s turn.
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Amid US Cough Syrup Findings, Regulators Feel India Needs To Work On Perceptions But Also Make Improvements
In wake of the furore caused by OTC cough syrups made by two small Indian companies, former and current US FDA and MHRA officials say quality-related issues are not specific to India. However, while image management needs some work, manufacturers in the country also need to make further improvements to ensure quality.
Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate
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.
US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections
A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.