The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

“Designing treatments unique to individual patients has always been the promised goal of personalized medicine. After 25 years the FDA has, for the first time, outlined a framework to facilitate these ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...

Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to ...

The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...

New FDA guidelines for personalized genomic drug development are a step forward in advancing new therapies for ultrarare diseases, but industry leaders need further clarification.

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...

Makary urged the Trump administration to partner with the pharmaceutical industry. ・The senior official is of the opinion ...