Table of Contents
Why are FDA approved clinical trials important?
Clinical trials are conducted for many reasons: to determine whether a new drug or device is safe and effective for people to use. to study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.
Do clinical trials need FDA approval?
Clinical trials are an integral part of new product discovery and development and are required by the Food and Drug Administration before a new product can be brought to the market.
What are the provisions of the FDAMA for clinical trials?
Several of these provisions were specifically aimed at the clinical trial process. These include the Agreement/Determination meetings provisions and the least burdensome provisions (sections 201 and 205 of FDAMA, respectively).
What does the FDA do to increase diversity in clinical trials?
FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Learn more about FDA’s efforts to increase diversity in clinical trials. Where are clinical trials conducted?
Should cancer clinical trials include placebo control groups?
In clinical trials that include placebos, quite often neither patients nor their doctors know who is receiving the placebo and how is being treated with the experimental drug. Many cancer clinical trials, as well as trials for other serious and life-threatening conditions, do not include placebo control groups.
What does the FDA’s new device manufacturing rule mean for sponsors?
This new section of the act establishes criteria that allow sponsors to make certain modifications to the investigational device, including manufacturing changes, and/or to the clinical protocol during the course of the clinical investigation without prior FDA approval.