What’s the deal with the Food and Drug Administration?

My treatment for fibroids involves both drugs and medical devices. I thought I would include some information about the Food and Drug Administration since it is the government agency in the United States responsible for the approval of such things. From their mission statement, the FDA:

  1. Promotes and protects the public health by helping safe and effective products reach the market in a timely way
  2. Monitors products for continued safety after they are in use
  3. Helps the public get the accurate, science-based information needed to improve health

If you get the chance, wander over to the US Food and Drug Administration site. I suggest checking out:

An Overview of FDA (good place to start)

Center for Drug Evaluation and Research
(great resource to find drug information including Safety Alerts)

Center for Devices and Radiological Health
(medical device approvals, recalls, even stuff about cell phone safety)

FDA Electronic Reading Room
(if you EVER need tons to read, click on a few categories here)

MedWatch (more safety information plus medical product reporting)

Clinical Trials – Consumers and Patients
Clinical Trials – Health Professionals

Perhaps I should have put this last link near the top because I feel it is one of the most important. Please read “The FDA’s Drug Review Process“. Directly pulled this quote so you get the idea of “risk vs. benefit” during drug review:

“Once a new drug application is filed, an FDA review team–medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts–evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use. No drug is absolutely safe; all drugs have side effects. “Safe” in this sense means that the benefits of the drug appear to outweigh the risks.”

I added the italics and bold lettering for emphasis. Point one: sponsors (drug companies, research institutions, others) submit their clinical study information to the FDA for evaluation. Point two: NO drug is absolutely safe. The FDA considers “benefit vs. risk”. So should you when thinking about a particular treatment option.

Now, I’m ready to start talking about the individual stages of my fibroid tumor treatment plan.

Posted in Fibroids, Health, Life, Medical Decisions, Medicine, Personal, Random Notes, Science, Women's Health. Comments Off on What’s the deal with the Food and Drug Administration?
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