The FDA has issued a revised guidance on medtech manufacturers' obligations to notify the agency of manufacturing ...

Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal ...

A new major federal report says having more than seven drinks per week carries a 1 in 1,000 risk of dying from alcohol use.

AI is safe and trustworthy when deployed in healthcare. The plan emphasizes technical assistance for under-resourced ...

Final guidance from FDA affirms previously proposed caps for lead in packaged baby and toddler food that public health advocates complained did not go far enough – spurring calls for state action.

The FDA has set maximum levels for lead in packaged processed foods sold in jars, pouches, tubs or boxes. Here's what to know ...

New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...

The agency issued final guidance that it estimated could reduce lead exposure ... they’re based more on industry feasibility ...

From the cancer risk analyses by Health Canada (1996), the United States Environmental Protection Agency (US EPA 2000 ... m 3 (the upper bound of the range presented by US EPA (2000)). Guidance on ...

Industry watchers are eyeing areas that the administration will target to protect the public health, a motive that could impact agency guidance. The FDA’s draft plan proposed to issue more Level 1 ...

“Only the Governor can order law enforcement agencies or the national guard to assist the department in enforcing public health emergency measures, not the Secretary.” According to ...