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<p>[QUOTE="Anonymous, post: 4818990"]You still have no clue what you are talking about. The definition has not been, nor will ever be changed. Instead, the clinical data requirements can vary from product to product. With simple products, such as immediate release oral drugs, simple blood studies are sufficient. Drug with alternate route of delivery or other unique actions typically require FDA guidance on what will be required. At this point, there has not been any clear guidance, despite attempts by very large generic companies. Even if some guidance magically comes out today, it will take years of development and clinical work before we would even see a submission and then approval on generics are taking 2+ years after submission. </p><p><br /></p><p>Like always, we see posts like this person that makes comments that lack facts and demonstrate low intellect.[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 4818990"]You still have no clue what you are talking about. The definition has not been, nor will ever be changed. Instead, the clinical data requirements can vary from product to product. With simple products, such as immediate release oral drugs, simple blood studies are sufficient. Drug with alternate route of delivery or other unique actions typically require FDA guidance on what will be required. At this point, there has not been any clear guidance, despite attempts by very large generic companies. Even if some guidance magically comes out today, it will take years of development and clinical work before we would even see a submission and then approval on generics are taking 2+ years after submission. Like always, we see posts like this person that makes comments that lack facts and demonstrate low intellect.[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
GlaxoSmithKline
>
Diedre's call
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
GlaxoSmithKline
>
Diedre's call
>