Article Summary:
This week’s FDA update covers a range of regulatory developments. First, the agency transitioned from the Quality System Regulation (QSR) to the more globally harmonized Quality Management System Regulation (QMSR), publishing revised guidances to support the transition. FDA also launched its PreCheck pilot program to strengthen the domestic pharmaceutical supply chain and provide greater regulatory predictability.
The report notes concerns raised by staff and former officials about the Commissioner’s National Priority Voucher program, which aims to expedite drugs considered national priorities but may lack sufficient regulatory oversight. The White House also launched a website, TrumpRx.gov, to help consumers find discounted brand-name drugs.
In other news, FDA is allowing food producers to claim “no artificial colors” if they use natural dyes, and approved new food coloring ingredients. The Health and Human Services Office of Inspector General is investigating potential conflicts of interest involving an FDA deputy chief of staff. Congress has reauthorized FDA’s rare pediatric disease priority review voucher program.
The summary also covers several drug and medical device regulatory actions. FDA rejected Corcept Therapeutics’ drug relacorilant and issued a warning about companies marketing “illegal copycat drugs.” Amgen rejected FDA’s call to withdraw its drug avacopan. FDA published new guidance on patient preference studies and updated labeling for cancer drugs. Finally, Abbott Diabetes Care issued a Class I recall for certain Freestyle Libre 3 CGM sensors due to inaccurate blood glucose readings, prompting an FDA warning letter.