Medical Device Legal News with Sam Bernstein: Episode 9
On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more
On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for...more
In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation. The Draft Guideline updates the previous guideline on TMF that...more