When a person goes into a Walmart or Walgreens or CVS they probably do not realize how long it took to actually get the drug on the shelf or drug become available to be picked up at a local pharmacy. There is four phase to the FDA’s Approval Process: Pre-Clinical, Clinical, NDA Review, and Post Marketing. There are steps within all the phase that need to be completed before going to the next phase until a drug is made available to the public.
During the Pre-Clinical phase there are three steps that have to be completed before going to the next phase, which is the drug being developed, animal testing, and Investigational New Drug (IND) Application stages. The drug being developed stage is when a drug manufacturer creates a brand-new drug compound …show more content…
The review meeting is when the FDA comes together with the drug manufacturer before submitting of an NDA. The NDA is when the drug manufacturer officially requests to the FDA approval of a drug for marketing purposes in the U.S... An NDA is composed of all animal data, human data, examination of data, and data about how it is manufactured. The application review comes after an NDA is accepted then the FDA has 60 days to determine to file it so it can be reviewed. If the FDA decides to file the NDA, the FDA review team is selected and given the responsibility to check out the manufacturer’s research on the drug’s efficiency and safety. This step is two of the six steps during this process. During the drug labeling step, the FDA checks the drug’s professional labeling and to make certain the correct data is passed on to the health care consumers and practitioners. During the facility inspection steps, the FDA checks out and goes through the facilities where the drug will be produced. Of course, the final step is the FDA drug approval, which is when the FDA evaluator will decide to sign off and approve the application or decide to issue a response letter for disapproval. ("How Drugs Are Developed And Approved",
During the Pre-Clinical phase there are three steps that have to be completed before going to the next phase, which is the drug being developed, animal testing, and Investigational New Drug (IND) Application stages. The drug being developed stage is when a drug manufacturer creates a brand-new drug compound …show more content…
The review meeting is when the FDA comes together with the drug manufacturer before submitting of an NDA. The NDA is when the drug manufacturer officially requests to the FDA approval of a drug for marketing purposes in the U.S... An NDA is composed of all animal data, human data, examination of data, and data about how it is manufactured. The application review comes after an NDA is accepted then the FDA has 60 days to determine to file it so it can be reviewed. If the FDA decides to file the NDA, the FDA review team is selected and given the responsibility to check out the manufacturer’s research on the drug’s efficiency and safety. This step is two of the six steps during this process. During the drug labeling step, the FDA checks the drug’s professional labeling and to make certain the correct data is passed on to the health care consumers and practitioners. During the facility inspection steps, the FDA checks out and goes through the facilities where the drug will be produced. Of course, the final step is the FDA drug approval, which is when the FDA evaluator will decide to sign off and approve the application or decide to issue a response letter for disapproval. ("How Drugs Are Developed And Approved",