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<p>[QUOTE="anonymous, post: 6161828"]FDA's <a href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=abe2be1877bff909bf82dfbf10441331&term_occur=4&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" target="_blank" class="externalLink ProxyLink" data-proxy-href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=abe2be1877bff909bf82dfbf10441331&term_occur=4&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" rel="nofollow">tentative approval</a> of a <a href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=f01a6491fb3b489cb6ed3b4663fd83e4&term_occur=6&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" target="_blank" class="externalLink ProxyLink" data-proxy-href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=f01a6491fb3b489cb6ed3b4663fd83e4&term_occur=6&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" rel="nofollow">drug product</a> is based on information available to FDA at the time of the tentative <a href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=1e92b70e13af07efd50d2df61daffd8b&term_occur=7&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" target="_blank" class="externalLink ProxyLink" data-proxy-href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=1e92b70e13af07efd50d2df61daffd8b&term_occur=7&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" rel="nofollow">approval letter</a> (i.e., information in the ANDA and the status of current good manufacturing practices of the facilities used in the manufacturing and testing of the drug product) and is therefore subject to change on the basis of new information that may come to FDA's attention. A new <a href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=f01a6491fb3b489cb6ed3b4663fd83e4&term_occur=7&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" target="_blank" class="externalLink ProxyLink" data-proxy-href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=f01a6491fb3b489cb6ed3b4663fd83e4&term_occur=7&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" rel="nofollow">drug product</a> may not be marketed until the <a href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=7dee7e957d44bee5f59bb312504a885f&term_occur=2&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" target="_blank" class="externalLink ProxyLink" data-proxy-href="https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=7dee7e957d44bee5f59bb312504a885f&term_occur=2&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105" rel="nofollow">date of approval</a>.[/QUOTE]</p><p><br /></p>
[QUOTE="anonymous, post: 6161828"]FDA's [URL='https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=abe2be1877bff909bf82dfbf10441331&term_occur=4&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105']tentative approval[/URL] of a [URL='https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=f01a6491fb3b489cb6ed3b4663fd83e4&term_occur=6&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105']drug product[/URL] is based on information available to FDA at the time of the tentative [URL='https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=1e92b70e13af07efd50d2df61daffd8b&term_occur=7&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105']approval letter[/URL] (i.e., information in the ANDA and the status of current good manufacturing practices of the facilities used in the manufacturing and testing of the drug product) and is therefore subject to change on the basis of new information that may come to FDA's attention. A new [URL='https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=f01a6491fb3b489cb6ed3b4663fd83e4&term_occur=7&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105']drug product[/URL] may not be marketed until the [URL='https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=7dee7e957d44bee5f59bb312504a885f&term_occur=2&term_src=Title:21:Chapter:I:Subchapter:D:Part:314:Subpart:D:314.105']date of approval[/URL].[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Braeburn Pharmaceuticals
>
Not Allowed to Market in US!
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Braeburn Pharmaceuticals
>
Not Allowed to Market in US!
>