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FDA helps explain food labels and packaging terms

The FDA provides guidance explaining food ingredient and packaging terms that help businesses better understand labels, ...

Experts say the estrogen patch shortage could last a year—but the FDA label change isn’t the main culprit

Following a massive 162 percent surge in prescriptions and a major FDA label reversal, a critical shortage of estradiol ...

FDA adds caffeine labeling to regulatory priority list

The disclosure comes after Celsius and other energy drink manufacturers face mounting scrutiny for allegedly failing to ...

Testosterone Therapy Labels And Limits May Change Under FDA Proposal

Second, the changes would ease longstanding warnings about the use of the hormone therapy in those with prostate cancer. Current labels say testosterone should not be used in men ...
CNN

FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect

In December, the FDA finalized a rule that updates the nutritional requirements a human food item must meet to claim on its packaging that it is “healthy.” That rule was published with an effective ...
Endovascular Today

FDA Approves Updated Labeling of Gore Excluder EVAR Devices for Ruptured AAAs

Gore & Associates announced that the FDA approved updated labeling for the Gore Excluder abdominal aortic aneurysm (AAA) ...
The American Journal of Managed Care

FDA Expands Upadacitinib Label for Treating Inflammatory Bowel Disease

Upadacitinib is now approved for IBD patients unsuitable for TNF blockers after one systemic therapy, broadening treatment options. Clinical trials show upadacitinib's efficacy in achieving remission ...
Health AffairsOpinion

The Supreme Court Protected Generics. Now FDA Must Navigate The Aftermath

The Hikma Court correctly held that a generic manufacturer should not be liable for induced patent infringement if it carves ...
RAPS

FDA drafts guidance on drug interaction labeling

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...
RAPS

What's Holding up FDA's Electronic Drug Labeling Rule?

Legislators with the two committees that oversee the US Food and Drug Administration (FDA) want to know: What's holding up the agency's electronic labeling rule for pharmaceuticals? Prescription drug ...
Health Affairs

New Cancer Drug Approvals: Less Than Half Of Important Clinical Trial Uncertainties Reported By The FDA To Clinicians, 2019–22

Uncertainties about the benefits and harms of new drugs are common at the time of drugs’ approval. It is unclear to what extent the Food and Drug Administration (FDA) communicates these uncertainties ...