article thumbnail

STAT+: Drug may make chemotherapies less effective in cancer patients with obesity — but many doctors are in the dark

STAT

The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population. As the original brand-name manufacturer, however, Merck continues to have legal responsibility for the labeling, which means that all available versions lack the details.

article thumbnail

HLTH24: Here’s a first look at a draft 'nutrition label' for health AI

Fierce Healthcare

The Coalition for Health AI released a draft of their AI model card, or “nutrition label” for AI, filled out with information from AI imaging company Aidoc. LAS VEGAS—The Coalition for Health AI unveiled the first applied model card, completed by AI imaging company Aidoc. |

Labelling 126
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Proposes Front-of-Package Nutrition Label for Most Packaged Foods

Pharmacy Times

If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.

Packaging 144
article thumbnail

Antibiotic Minimum Inhibitory Concentrations: Do You know These 6 Things About Them?

IDStewardship

In this article an infectious diseases pharmacist discusses important information to know about antibiotic minimum inhibitory concentrations. coli listed as susceptibleor resistant to a battery of drugs – then know there are MICs available somewhere that have informed those results. Authored By: Timothy P. Gauthier, Pharm.D.,

Labelling 130
article thumbnail

It’s the Law Now –Cybersecurity Information in Premarket Submissions

The FDA Law Blog

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Loose Ends IDEs.

FDA 105
article thumbnail

FDA gives go-ahead on labelling for Cumberland’s therapy for fever and pain in infants

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.

article thumbnail

PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

The FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A 513(g) Request for Information is a means of obtaining FDA’s views about the classification and regulatory requirements for a particular device.

FDA 98