Drug Development & FDA Regulations Trailer



welcome to drug development and FDA regulations you'll see the slides on your screen today and you'll also see three tabs at the top with three different FDA forms these are the most current forms and they've just recently come about so you want to make sure that anything that you happen to be dealing with the FDA if you do have older forms you need to get rid of those and use these newer versions that are the 2016 ones in all cases they've just updated them slightly not many changes but you want to make sure your regulatory groups are using these ones that are now available so as we get started today we'll walk you through the whole process of course the generic will be a subset of that because you're not going to have to do is extensive a workup but it's good to know what goes on on the on the e non generic type of products and then where we're in case you ever are working in a non-proprietary typesetting you'll understand the whole FDA process so that will be a good complete review than for you so if we look at the first slide and again if you have any questions or comments just go to the chat panel at the bottom and send it to all participants and type in your little message I'll be monitoring that as we go across the session today and again any proprietary information leave until the end and I'll be glad to answer any questions that I might be able to help you with so our learning objectives today are several the first is to look at FDA's role in drug development you notice the FDA Food and Drug Administration and yet they handle a lot of other types of products such as medical devices such as vitamins supplements but those are not reflected in the title of their their group it's called Food and Drug Administration there are sub sets under that for each of the other types of products that they will actually manage in the United States we're going to review the logic behind the drug development process it is a very logical situation will talk about the IND investigative new drug application and why you need one of those we'll also talk about a new drug application to let us market that product and what goes into that from the FDA what does that review like we'll talk about the basics of the clinical trial process all the various phases from the very beginning the laboratory work that goes into it that would be done by good laboratory practices the clinical pieces the phase one for human volunteers the phase two where we look at dose-ranging the phase three where we would actually compared to any other available product that might be marketed for that indication and then we'll look at the NDA the application for marketing and also just a bit about the post marketing phase for all done within good clinical practices that's where your generic products will come in as well you'll be doing bioavailability and bioequivalence studies you wouldn't go through the entire face 1 through 4 process since the product that you're comparing to is already would already be marketed so we'll talk a bit about it and then we'll look at the FDA's review process what is it that they actually look at when they give permission for a company to conduct clinical trials and what do they review to see if it's safe and effective to be marketed in the United States and then we'll look at the three major regulations that are involved across the board good clinical practice good laboratory practice and also good manufacturing practice you

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