Explaining the FDA Approval Process
How Real World Experience
from Patients Waiting for a Drug’s Approval is an Important Element in the FDA
Review Process
The FDA drug approval process can seem complex and arduous to
people unfamiliar with the procedures that are in place. For people with rare
diseases hoping for drugs to be approved, one of the toughest but most
important virtues they need is patience.
Most drugs that undergo preclinical (animal)
testing never even make it to human testing and review by the FDA. The drugs
that do must undergo the agency's rigorous evaluation process, which
scrutinizes everything about the drug--from the design of clinical trials, to
the severity of side effects and even the conditions under which the drug is
manufactured. 1 It
can take a decade or more to go through the full clinical process and be
considered for approval.
This patience can truly be tested when the one
waiting for the drug approval is a child with a rare disease. Children
suffering from certain diseases are no different from any other group awaiting
approval for promising drugs. See more.
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