A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant ...
The dramatic shift in oversight comes at a time when the U.S. has never been more reliant on foreign food, which accounts for ...
First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period Monthly dosing ...
The same company whose infant formula is now under recall in relation to an outbreak of botulism poisoning cases recalled its ...
Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of the largest employers in Lexington, has continued to face federal ...
The U.S. FDA inspection of the facility, Unit-II in Bhiwadi, Alwar, from November 3-14 concluded with nine observations. They are procedural in nature and will be responded to within the stipulated ...
Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
With a federal government shutdown now in effect, FDA has activated its FY 2026 contingency staffing plan. While essential safety activities and user fee–funded reviews will continue, many programs ...
The first wave of Commissioner’s National Priority Vouchers signals a fundamental shift in FDA competitiveness, rewarding companies that pair breakthrough science with affordability commitments, ...
If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news coverage since late October 2025 about an extensive recall of thousands of bottles of atorvastatin, the ...
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