The course offers key opportunities in understanding U.S. medical device approval pathways, including 510(k), IDE, PMA, and De Novo. It enhances practical skills through interactive case studies and ...

"With the FDA recently saying too many [medical] devices are getting approved too easily and some other things they are articulating, it's frustrating," Montage Systems CEO Eric Collins said during a ...

Working with Parent Project Muscular Dystrophy and the Duchenne Registry on patient identification and trial awareness efforts ~15,000 children ...

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

Replimune Group Inc. REPL on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for ...

Eli Lilly's new daily pill GLP-1 moved through the FDA approval process faster after the FDA's new review and approval process.