The Food and Drug Administration’s Typical Process for Approving New Drugs

The Code of the Federal Register (CFR) are written policies not quite as powerful as statutes passed by Congress. CFR, Title 21, subchapter D, entitled “Drugs for Human Use” provides the regulations that are relevant to most pharmaceutical litigation. Importantly, these CFR sections set forth the requirements of New Drug Applications (“NDA”) and Abbreviated New Drug Applications (“ANDA”). Drugs approved through New Drug Applications are “branded” drugs; those approved through ANDAs (pronounced as one word “and-uhs”) are “generic” drugs.

conduct a series of tests demonstrating that the product is reasonably safe and will likely be effective in humans. The sponsor does this through chemical testing. Next, the sponsor conducts “preclinical trials” on animals. Once the FDA is satisfied with the evidence presented, it issues an Investigational New Drug Application (INDA). The INDA is permission for the sponsor to conduct testing on people. These tests are known as “clinical trials.”

There are phases of clinical trials. “Phase O” clinical trials are first. The goal of the Phase O clinical trial is to learn how a drug is processed in the human body. A very small dose is given to a very small number of people.

Next, drug sponsors conduct “Phase I” trials. Again, these trials involve a very small number of study subjects, sometimes as few as 20-30 people. The goal of these trials is to detect side effects in humans or determine how side effects increase when the dosage is increased.

“Phase II” clinical trials involve a larger group of individuals. This trial phase is about efficacy or the ability to produce a desired or intended result. Clinicians ask “Does the drug work and if so, how much of the drug must someone ingest to make it work?”

“Phase III” clinical trials involve a larger group of people. This phase often involves double-blinding, meaning that neither the study participants nor the people who work directly with study participants know whether any particular study subject has been given placebo, the test drug, or even another drug.

“Phase IV” clinical trials take place after approval by the FDA, usually to obtain more information about both safety and efficacy over more time.

The FDA will issue an NDA only after the sponsor has spent hundreds of millions of dollars and, typically, several years “proving” a drug is safe and effective. The NDA holder must also go through several rounds of negotiations with FDA to determine the contents of the labeling.

Abbreviated New Drug Applications

The requirements to obtain an Abbreviated New Drug Application are much less expensive and time consuming for the sponsor. The sponsor needs only to demonstrate that its product is bioequivalent to the brand and that its label is materially the same as the “branded” product.

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