FDA wants to regulate thousands of lab tests that have long skirted oversightThe Food and Drug Administration says it plans to begin regulating laboratory-based medical tests.
FDA forces unproven premature birth drug Makena off marketThe Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market.
FDA's tobacco unit pledges reset after criticismThe Food and Drug Administration is pledging a reset in the agencyโs tobacco program.
No cow needed: Oat, soy, almond can be called milk, FDA proposesDraft U.S. rules would allow soy, oat, almond and other drinks that bill themselves as โmilkโ to keep using the name.
FDAโs own reputation could be restraining its misinfo fightThe U.S. Food and Drug Administration is taking aim at a new health hazard: online misinformation.
FDA revamping foods program to move past โconstant turmoilโThe head of the Food and Drug Administration has announced an overhaul of the agency's food safety and nutrition division.
FDA food safety official resigns, cites structural issuesThe Food and Drug Administration's top food safety official has resigned.
Panel warns FDAโs beleaguered tobacco unit lacks directionA new report criticizes the Food and Drug Administrationโs efforts to oversee the tobacco industry, including traditional cigarettes and vaping products.
Speedier drug approvals hit slowdown as FDA faces scrutinyThe Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs.
Panel calls for stronger leadership of FDA foods programA panel is calling for changes at the federal agency that oversees most of the nation's food supply, saying revamped leadership, a clear mission and more urgency are needed to prevent illness outbreaks and to promote good health.
FDA panel backs removal of unproven pregnancy drugA panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn't work.
US outlines plan for long-term baby formula importsU.S. regulators have revealed their plan to allow foreign baby formula manufactures to stay on the market long term.
Insider Q&A: FDA official on vaping's "promise or peril"The new chief at the Food and Drug Administration's tobacco center has inherited a raft of problems.
FDA concedes delays in response to baby formula shortageU.S. health regulators say their response to the ongoing infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nationโs largest formula factory.
US warns monkeypox could mutate to resist antiviral drugU.S. health officials are warning doctors against overusing the lone drug available to treat monkeypox.
FDA chief says long-awaited opioid review still in the worksThe head of the Food and Drug Administration says a government review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway.
FDA targets illegal nicotine gummies in new warning letterU.S. regulators have issued a warning letter to the maker of illegal nicotine gummies.
FDA chief's long-promised opioid review faces skepticismThe head of the Food and Drug Administration says a comprehensive review of the opioid painkillers that triggered the nation's ongoing overdose epidemic is in the works.
FDA weighs oversight changes after formula, Juul troublesThe head of the Food and Drug Administration is asking for a review of the agencyโs food and tobacco programs.
US regulators OK new COVID-19 shot option from NovavaxThe U.S. is getting another COVID-19 vaccine choice.
Abbott baby formula plant stops production following severe weatherAbbott announced that it has put a halt on production at its Michigan plant following severe thunderstorms and heavy rains in the region Monday that resulted in power outages and flood damage.
Many baby formula plants weren't inspected because of COVIDU.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020.
Abbott restarts baby formula plant linked to contaminationAbbott says it's restarted production at the Michigan factory that's tied to the ongoing baby formula shortage.
FDA chief struggles to explain slow response on baby formulaThe head of the Food and Drug Administration testified about a series of setbacks that led to a months-long delay in inspecting the plant at the center of a nationwide baby formula shortage.
FDA head: Baby formula factory could reopen by next weekThe Food and Drug Administration's commissioner says a shuttered baby formula factory could be up and running by next week.
US allows more baby formula imports to fight shortagePresident Joe Biden's administration has announced new steps to ease the national shortage of baby formula, including allowing more imports from overseas.
FDA issues plan to ban menthol in cigarettes, cigarsThe U.S. government has released its long-awaited plan to ban menthol cigarettes and flavored cigars.
Biden agency vacancies to drag on White House prioritiesVacant high-ranking positions across the executive branch could be taking a toll on the Biden administration.
Senate confirms Biden's FDA pick despite political divisionsThe Senate has narrowly confirmed President Joe Bidenโs pick to lead the Food and Drug Administration, filling a position that had been open for more than a year.
FDA's agenda in limbo as Biden's nominee stalls in SenatePresident Joe Bidenโs pick to lead the powerful Food and Drug Administration has stalled in the narrowly divided Senate.
FDA pick parries questions at collegial confirmation hearingPresident Joe Bidenโs pick to lead the Food and Drug Administration deftly parried questions on crises ranging from the COVID pandemic to the opioid epidemic.
Biden picks ex-FDA chief Robert Califf to again lead agencyPresident Joe Biden is nominating former Food and Drug Administration Commissioner Dr. Robert Califf to again lead the powerful regulatory agency.