Step #2: Dig Into The PDUFA Dates That You’ve Chosen

Now that you’ve got your list of PDUFA dates in hand, it’s time to do your research. Keep in mind that for a PDUFA date to exist, a New Drug Application or Biologics License Application has to have been submitted.

This means that if there is a PDUFA date, there is tons of information that is available. In general, before a New Drug Application or Biologics License Application is submitted the following four key events will take place:

  • Preclinical Studies – These studies take place in non-human subjects. The subjects may be animals or other organisms. The ultimate goal is to show that the drug or biologic agent is safe for use before providing the treatment to a human population.
  • Phase 1 Clinical Studies – Phase 1 clinical studies are generally the first point of contact between human patients and a new drug. These studies often take place among healthy individuals with an attempt to determine the maximum tolerated dose of the new drug or biologic.
  • Phase 2 Clinical Studies – Phase 2 clinical studies are more of a proof of concept type of study. In most cases, in the second phase, new drugs and biologics are provided to patients with confirmed illnesses in place of the current standard of care. Phase 2 studies generally include small patient populations with the goal of proving that in the chosen patient population the drug has a statistically significant effect.
  • Phase 3 Clinical Studies – Finally, Phase 3 clinical studies are generally the last step before a New Drug Application or Biologics License Application is submitted. In these studies, large patient populations are generally provided with the experimental treatment instead of the standard of care. The goal of these studies is to show that among most patients with a given illness, the experimental treatment is successful and producing a statistically significantly improved outcome.

With a simple Google search, you’ll be able to find data from each and every one of these events. You can also search the FDA website for further information on any given experimental drug.

Take your time to read all of the data that you can find, and make a prediction as to whether or not you believe that the drug will be approved. If not, it’s time to scratch the drug off of your list. If so, it’s time to move on to Step #3:

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