Tag: Food & Drug Administration
FDA Panel Meets to Craft Future Vaccine Strategy
No official vote is planned, and no specific vaccine products will be discussed
FDA Warns of U.S. Norovirus Cases Linked to Canadian Oysters
Oysters were distributed in 13 states, but others may also have received them through further distribution within the United States
FDA Advisory Panel Narrowly Votes Against New ALS Drug
Panelists said they hoped results of a larger study, now underway, would provide more evidence on the drug
FDA Reviewers Give Thumbs Down to New ALS Drug
Agency said results were 'not persuasive,' citing missing data, mistakes in enlisting patients, other issues
FDA Says Gene-Edited Cattle Are Safe to Eat
Cattle are the third genetically altered animals approved for human consumption after salmon and pigs
FDA Expands Approval of Jardiance for Patients With Heart Failure
Jardiance received approval to reduce the risk for cardiovascular death and hospitalization for patients with heart failure
FDA Approves Marketing of First Condom Designed for Anal Sex
Condom was approved through the De Novo premarket review pathway for low- to moderate-risk devices of a new type
FDA Warns of Rising Dangers of Unapproved Drug Tianeptine
Possible risks from taking the drug include accidental poisoning and addiction
FDA Warns of Infant Formula Powders Tied to Infections
Agency is investigating three Cronobacter sakazakii infections and one Salmonella Newport infection among four infants
U.S. Senate Narrowly Confirms Califf to Head FDA
Califf briefly served as FDA commissioner toward the end of President Barack Obama's administration
