5 Things You Need to Know About the Drug Approval Process

Safe and effective drugs are essential to
caring for your patients. So here are 5 things to know about how FDA
approves a drug for use. It starts when a drug is investigated and
screened. Generally, New drugs are tested on animals
before people. Additionally, in some cases, multiple species
are used to gather information on the safety of the compound being investigated. The drug sponsor submits an investigational
new drug application (IND) to the FDA based on the results of the initial testing. The application is required to include the
drug’s composition, as well as the details of its manufacturing. The IND presents a plan for testing the drug
on humans. The FDA reviews the plan to determine if the
proposed clinical trials will put human subjects at unreasonable and significant risk of illness
or injury. Generally, there are three phases to a clinical
trial in humans. Phase one emphasizes safety and typically
includes 20-80 healthy volunteers. Phase 2 emphasizes effectiveness and typically
includes hundreds of patients with a certain disease or condition. Phase 3 typically includes thousands of patients
and is used to gather more information about the safety and effectiveness in different
populations and different doses. After the clinical trials are complete the
FDA looks carefully at all the animal and human testing data, reviews the drug labeling
information, and inspects the facilities where the drugs will be manufactured to determine
if the new drug is safe and effective. Because it’s not possible to predict all of
a drug’s effects during clinical trials, monitoring safety issues after drugs get on the market
is critical. The role of FDA’s post-marketing safety
system is to detect adverse events and take regulatory action when needed. That’s five things you need to know about
the drug approval process.

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