How are medicines approved for human consumption?
                     How Are 
Medicines 
Approved For 
Human 
Consumption?
Introduction
The FDA’s approval process has garnered 
many criticisms over the years. For one, 
generic drugs and devices often make it to 
market simply because the manufacturers 
can demonstrate they are similar to 
products that were approved in the past — 
even if those products have known safety 
concerns. 
Source: www.nps.org.au 
Approval 
Processes
A pharmaceutical company seeking FDA 
approval to sell a new prescription drug 
must complete a five-step process: 
discovery/concept, preclinical research, 
clinical research, FDA review and FDA post-
market safety monitoring.
Source: www.nps.org.au 
Step 1
First, the company must conduct 
laboratory tests and try the drug on 
animals and then people to make sure it 
works and is safe.
Manufacturing information to demonstrate 
the company can properly manufacture the 
drug
The company’s proposed label for the 
drug, which includes uses for which it has 
been shown to be effective, possible risks 
and how to use it
Source: www.nps.org.au 
Step 2
FDA physicians and scientists then review 
the drug research and the labeling 
information on how to use the drug. If the 
findings show the drug’s benefits outweigh 
its known risks — and that the drug can be 
manufactured in a way that ensures a 
quality product. 
The FDA will continue to monitor the drug 
post-approval.
Source: www.nps.org.au 
Step 3
Generic-drug companies must prove that 
the ingredient in the drug that is effective 
against the illness or condition it’s treating 
is the same as that of the brand-name 
drug.
The application for generic drugs is the 
Abbreviated New Drug Application (ANDA). 
It’s called “abbreviated” because drug 
companies don’t need to include animal 
and human data to establish safety and 
effectiveness.
Source: www.nps.org.au 
Drug 
Patents
Federal law allows generic-drug companies 
to work on drugs to gain FDA approval 
before the patents held by the brand-name 
companies expire. 
However, when a generic-drug maker files 
an application with the FDA, it must notify 
the patent holder if it’s challenging the 
patent that exists, meaning if the generic-
drug maker is claiming the generic drug 
doesn’t infringe on the brand patent or the 
patent isn’t valid.
Source: www.nps.org.au 
Pay for 
Delay
There’s no shortage of controversy in the 
prescription-drug business, with current 
practices employed by drug companies 
garnering both support and criticism. 
Perhaps the biggest controversy today is a 
concept called “pay-for-delay.”
Source: www.nps.org.au 
Over-the–
Counter 
OTC drDugs trhatu follogw asn existing 
monograph can be sold without further 
FDA review. Those that do not conform to a 
monograph must undergo the NDA 
process. 
The FDA continually updates OTC drug 
monographs to include additional 
ingredients and labeling as needed.
Source: www.nps.org.au 
Faster 
Approvals
PDUFA has allowed the Food and Drug 
Administration to bring access to new 
drugs as fast or faster than anywhere in 
the world.
Since PDUFA was passed in 1992, more 
than 1,000 drugs and biologics have come 
to the market.
Source: www.nps.org.au