Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

The idea of a purge followed by a blender is new, but the idea of a ‘supercenter’ isn’t. Back in 1982, FDA’s Bureau of Drugs ...

A session dives into the trends surrounding specialty drugs and therapies, along with providing an overview of the drug ...

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices.

Quantum Leap Healthcare Collaborative (QLHC) is proud to announce the appointment of three distinguished leaders to its Board ...

The FDA has published its long-awaited update to ... Pazdur of the FDA’s Center for Drug Evaluation and Research (CDER). “The agency’s draft guidance is an important step – and one of ...

and critical care at the FDA Centre for Drug Evaluation and Research (CDER), said the approval is "a major step forward for patients." OSA results in repeated interruptions in breathing during ...

In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions ...

Food and Drug Administration officials have told some scientists and inspections staff that their layoffs will be reversed, after the job cuts led to disruptions in drug and food safety work.