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How to get F.D.A Approval for Clinical Trails
How to get FDA Approval
What is a clinical trial?
a clinical trial is a way to develop a new drug or a new surgery that can help improve the patients condition.
what is a clinical trial?
Types of applications
Types of applications
There are 4 main applications to apply under. The drugs can be applied under more than one only if they meet all the criteria
Breakthrough Therapy
This is designed to expedite the development and review of drugs that are believed to help with a serious condition the clinical evidence must show that the drug can demonstrate better improvement than over other available therapies. With the breakthrough therapy application, you can enter the fast track program because of similar criteria. The FDA may ask you to apply for the Breakthrough Therapy if they think the submitted data and information for a different path may meet the criteria of the Breakthrough Therapy or if drug development can benefit from the program. The submission for this program should be made before the end of phase 2 because the whole point of the program is to help develop the drug and get results.
Breakthrough Therapy
Fast Track
Fast Track
The fast track program is one way, but for this program to work in your favor your clinical drug or medication needs to follow the very strict guide lines. One of the biggest factors is the day to day survival of the patient. The fast track drug must show the most effective outcome compared to the other available treatments; it must also avoid serious side effects that the already available treatments have. The application must be submitted by the company that’s making the drugs.
Accelerated Approval
Accelerated Approval
The fastest way to get FDA approval is though Accelerated approval that’s when it’s a new drug for a disease that has no other treatments or medication like HIV/AIDS and even cancer drugs. The only criteria are that the benefits MUST outweigh the side effects to get and keep FDA approval. The FDA can take away approval if further use of the drug shows that the benefits are not outweighing the side effects
Priority Review
The Priority review was made to help speed up the review process of the clinical trial it trims the standard 10 months to 6 months. If approved though Priority review significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. The FDA will decide if your application is good for program based off the data sent.
Priority Review
Phase 0&1
these 2 phases are to help find the drugs that most frequently help the patients improve their condition
Phase 0&1
Phase 0
This phase is before the trail it self starts it`s where they chose what they want to do and start research and start testing ether on animals or on very few human patients to get some results to see what to fix. one of the biggest things they need to get is money or a grant from a company
Phase 1
This phase is to do more testing on human patients with more drugs to try and narrow down which drugs are working the best with the least amount of side effects. There`s usually doctors involved with the trials to do the testing.
Phase 1
Phase 2
This Phase is even more testing of the drug after sending in results and getting more money or another grant from the same company.
Phase 2
Phase 3
This phase is controlled by the drug company depending on which drugs from the last phase had the best results are used in a blind test. That means the doctors don`t know what drug they are going the patients in till its time to give it. This is done so there is no personal feeling involved with the trial the doctors might develop. once this phase the drug company can request FDA approval for going to market.
Phase 4
This is the last phase, at this point the company has a successful drug that helps the condition of patients along with that the drug has FDA approval and is able to go to be sold. Some of the things the companies do is continue to monitor the effectiveness of the drug and compare data of other drugs on the market that are like theirs.