Title 21: 1981

When you visit IMARC Research’s office, you will notice beautiful artwork on our lobby wall.  The artwork pays homage to key events in the history of clinical research.  We also released an eBook that describes all the images that make up the timeline and we encourage everyone to take advantage of this important information. In today’s day and age, it is a widely accepted and understood requirement that conducting clinical research for investigational new drugs and devices in the United States means that you will be responsible for following the FDA regulations. The terms, “according to the regulations, “or “according to the regs,” are used commonly, as we all have grown accustomed to these seemingly intuitive laws that govern the practice of clinical research. However, not too long ago, the regulations we freely refer to now did not exist. It wasn’t until after the 1979 Belmont Report, that FDA and the Department of Health and Human Services formally revised regulations for human subject protections by creating Title 21 – Food and Drugs. You might be surprised to learn that as recently as 1980 these regulations did not exist as they do today. It was this year that 21 CFR Part 50 – Protection of Human Subjects was issued. The following year, in 1981, 21 CFR Part 56 – Institutional Review Boards was issued. This same year, 21 CFR Part 50 was also amended. Since this time, these parts have seen continuous improvements through amendments over the y...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog IMARC Source Type: news