Here on MyMigraineConnection.com, a lot of the discussions, questions, and articles are about medications for Migraines and headaches. We're all interested in new medications that are being developed, and we're interested when the clinical trials are complete, and the FDA approves a medication for treating Migraine. Most recently, Teri and I have told you about successful clinical trials of the Zelrix sumatriptan patch and the approval of Botox for chronic Migraine. Have you ever wondered what happens after the clinical trials are completed and how the new drug is then FDA approved? Keep reading to find out.
The Center for Drug Evaluation and Research aka CDER (which is the biggest center of the FDA) evaluates the safety and effectiveness of the medication after Phase III clinical trials are completed. The staffers who evaluate the documentation, safety and pre-labeling drug data accumulated from the clinical trials, consist of doctors, statisticians, chemists, pharmacologists, and other scientists. If the sponsor (developer, usually a pharmaceutical company) of the drug has enough evidence and meets the CDER's criteria for approval, they will apply for a New Drug Application or NDA. This approval process takes into consideration whether or not the benefits of the drug outweigh the known risks, and make sure any unanswered questions are answered.
Phase IV clinical trials are conducted to determine if a drug or treatment is safe over time, or to see if a treatment or medication can be used in other circumstances. Phase IV clinical trials are done after a drug or other treatment is approved by the FDA and include postmarketing findings and any descriptive materials on the best way to use the new medication along with its risks and benefits. These trials are not FDA funded - but are conducted by pharmaceutical companies, medical institutions, various organizations and/or individuals such as physicians, foundations, and volunteer groups. Federal agencies may also conduct clinical trials and include; The National Institutes of Health (NIH), Department of Veterans Affairs (VA) and the Department of Defense (DOD).
Getting a new drug approved with the FDA is quite a long process, sometimes taking many years before it gets approval and is finally distributed. Each phase has its own criteria and, if not met, the entire project is stopped. All for the benefit of the consumer, which of course is us, the Migraineurs!
FDA. Food and Drug Administration. US Department of Health and Human Services. Drugs. How Drugs are Developed and Approved. April 23, 2010.
Bonk, Nancy Harris. "Update: Zelrix Sumatriptan Patch for Migraine." MyMigraineConnection.com. October 16, 2010.
Robert, Teri. "FDA Approves Botox for Migraine." MyMigraineConnection.com. October 18, 2010.
Feel well,© The HealthCentral Network, 2010
Last updated November 7, 2010
Published On: November 07, 2010