US Food and Drug Administration
Coverage of US Food and Drug Administration in the Nexus archive.
- Another popular pantry item recalled over potential salmonella contamination
A popular pantry item has been recalled due to potential salmonella contamination, linked to nearly a dozen recalls this month. The recalls are all connected to the same contaminated ingredient. Multiple products have been affected by the recall.
- The food recalls, alerts issued over salmonella concerns this month
There have been food recalls and alerts issued due to salmonella concerns this month. Many of the recalled items are linked to a potentially contaminated ingredient. The recalls highlight the need for food safety.
- FDA turmoil deepens as top drug chief departs claiming she was fired
The FDA is experiencing turmoil as top regulators, including Dr. Tracy Beth Høeg and Katherine Szarama, have left their positions, with Høeg claiming she was fired. The agency now lacks permanent leaders in key roles. This shake-up follows the resignation of Marty Makary.
- STAT+: Pharmalittle: We’re reading about FDA’s Makary resigning, a Lilly weight loss drug trial, and more
US Food and Drug Administration Commissioner Marty Makary is resigning, with Kyle Diamantas stepping in as acting commissioner. Eli Lilly's weight loss pill Foundayo was found to have patients regain an average of 2-11 pounds after switching from injectable medications. The FDA has been marked by personnel drama and controversy over political pressure.
- What to know about Kyle Diamantas, the new acting FDA commissioner
Kyle Diamantas is the new acting FDA commissioner, previously serving as deputy commissioner for food at the FDA. He was described by Donald Trump as a 'very talented person'. Diamantas has a background as a corporate lawyer, defending companies like formula makers.
- Marty Makary departs FDA after clashes over fruit-flavored vapes with Trump – reports
Marty Makary resigned as commissioner of the US Food and Drug Administration after a 13-month tenure, frequently drawing ire from the White House, Congress, industry, and the public. Kyle Diamantas will replace him as acting FDA commissioner. The resignation comes after clashes over fruit-flavored vapes with Trump.
- Health advocates warn government’s claims of baby formula safety contradict data
The Trump administration claims baby formula samples meet a high safety standard, but health advocates argue this contradicts data showing contamination with toxic chemicals like Pfas or phthalates. Independent scientists reviewed the results and raised concerns about data gaps and contamination. The US Food and Drug Administration expanded the testing program and made the results public.
- ‘The FDA is a complete mess’: Trump makes fate of agency chief unclear as public trust plummits
Donald Trump has signed off on a plan to potentially fire Marty Makary, the commissioner of the US Food and Drug Administration, due to controversial decisions and plummeting staff morale. The FDA has faced criticism over its handling of vaccine safety publications and regulatory decisions. Public trust in the agency has decreased amid these controversies.
- STAT+: Pharmalittle: We’re reading about an FDA gender rule change, its program for one-day inspections, and more
The FDA proposed a rule to remove references to 'gender' from its regulations, sparking concerns about research on gender minority populations. Louisiana urged the US Supreme Court to prevent abortion pills from being prescribed through telemedicine. The FDA also announced a program for one-day inspections.
- STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more
Sanofi has asked the FDA to pull its type 1 diabetes drug from a speedy review program after a staff decision to approve the drug was disagreed with by the acting Center for Drug Evaluation and Research Director. An experimental drug from Revolution Medicines has shown promise in clinical trials for advanced pancreas cancer. The FDA is rethinking its approach to drug approvals.
- ‘People should be talking about it’: moves to curtail vaccine information obscures important science, doctors say
US health agencies are being criticized for controlling public communications, potentially damaging public health by quashing vaccine safety studies and halting publications on Covid boosters. The FDA, CDC, and NIH have all been involved in decisions to limit research and information. This has raised concerns among scientists and doctors about the extent of agency control.
- Two US potato chip brands recalled amid salmonella concerns
Utz has issued a voluntary recall of Zapp's and Dirty potato chip brands due to potential salmonella contamination linked to seasoning. The recall applies to certain flavors and bag sizes of these products. The US Food and Drug Administration announced the recall on Monday.
- STAT+: Pharmalittle: We’re reading about a PhRMA ad campaign aimed at 340B, sales of Novo’s obesity pill, and more
The Pharmaceutical Research and Manufacturers of America is launching a seven-figure ad campaign targeting the 340B Drug Pricing Program, while the US Food and Drug Administration has seen an increase in rejection rates for cell and gene therapies. The program requires manufacturers to provide drugs at reduced prices to health providers caring for low-income patients. The ad campaign aims to manipulate the program's benefits.
- FDA blocked studies finding Covid and shingles vaccines safe, HHS official says
The US Food and Drug Administration blocked publication of studies finding Covid-19 and shingles vaccines safe. The studies, funded by taxpayer money, found serious side-effects from vaccines were rare. Agency scientists analyzed millions of patient records.
- FDA issues urgent recall of potato chips over contamination with deadly bacteria
The FDA has issued an urgent recall of potato chips due to contamination with deadly bacteria. The recall is intended to protect consumers from potential harm. The affected products are being removed from store shelves.