In part one of this two-part blog series, we went over the standard steps involved in the process of clinical researchers discovering and developing a new drug. The drug development process, one that’s strictly regulated by the Food and Drug Administration (FDA), follows a set of steps to allow for safe, sensible and timely development of new drugs that may aid with a variety of conditions.
At AGA Clinical Trials, we’re happy to offer a wide range of clinical trials for patients looking to participate, including many that contribute to the formulation of effective new drugs for various conditions or situations. In today’s part two of our series, we’ll go over the latter stages of the FDA’s drug development process to keep you informed on how a given drug moves through this procedure.
After stage two, or pre-clinical research, comes the primary research stage. This stage can only be entered if the drug in question is deemed safe and effective enough for human testing, a process that’s accomplished in earlier steps.
This stage begins with the outlining of a clinical research study, the sort we carry out regularly in our facilities. This outline contains information on the research questions hoping to be answered, the study’s purpose, participant selection criteria, drug dosage and more. This will be submitted to the FDA for approval – if approved, the study can begin. There are several phases of a given trial once it’s been approved, each of which involves data being submitted back to the FDA for review at the completion of every phase.
FDA Review Period
Once the clinical trials involved with a given drug have been conducted and deemed to be safe and effective for humans, researchers will submit a New Drug Application to the FDA for approval. The application will include things like drug labeling plans, safety information, data from the clinical trials and information on dosages.
The FDA will review this application in detail. They may ask for additional information, particularly related to prescribing information, before giving final approval. Once such approval is given, the drug can be marketed to the public.
Post-Market Safety Monitoring
Finally, the FDA will continue to monitor new drugs once they reach the public. It’s possibly for new scenarios to crop up here that may not have been tested for during trials, and the FDA may need to add things like label cautions, dosage restrictions or other interventions if there are serious issues with a given drug (this is rare, however). As long as the drug remains available to the public, the FDA will be keeping an eye on it.
For more on the process a new drug goes through before being approved for the public, or to learn about any of our medical trials that often help with this process, speak to the staff at AGA Clinical Trials today.