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Approval Process
Sponsor Conducts Phase 3
5 An even larger number of patients are selected for this phase, which gathers more information about
safety and effectiveness. This study includes different populations, different dosages, and uses the drug
in combination with other drugs.
FDA’s New Drug Application Review
Review Meeting
6 FDA meets with a drug sponsor prior to submission of a New Drug Application.
Sponsor Submits NDA Application
7 The drug sponsor formally asks FDA to approve a drug for marketing in the U.S. by submitting an NDA,
which includes all animal and human data, analyses of the data, how the drug behaves in the body, and
how it is manufactured.
FDA Reviews Application
8 The FDA has 60 days to decide whether to file the application for review. If the FDA files the NDA, a
review team is assigned to evaluate the sponsor’s research.
FDA Reviews Drug Labeling
9 FDA reviews the drug’s professional labeling and assures appropriate information is communicated to
health care professionals and consumers.
Facility Inspection
10 FDA inspects the facilities where the drug will be manufactured.
Drug Approval
11 FDA reviewers will approve the application or issue a complete response letter, which will describe the
specific deficiencies that the agency has identified in an application.
Continued Safety Measures:
FDA’s Risk Assessment Systems
Phase 4
Because it’s not possible to predict all of a drug’s effects during clinical trials, post-approval and post-marketing
safety monitoring is critical. The FDA’s safety system is meant to detect unexpected adverse events, and take
definitive action when needed, after the drug has been approved and marketed. The sponsor (typically the
manufacturer) is required to submit periodic safety updates to FDA.
FDA’s MedWatch voluntary system allows physicians and consumers to report adverse events. When
new risks are discovered, they are added to the drug’s labeling and the public is informed through letters, public
health advisories and other educational means. In some cases, the use of the drug might be substantially limited
and in rare cases, the drug might be withdrawn from the market. S
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