tag:blogger.com,1999:blog-4241416962008169508.post5610493529290810091..comments2024-03-27T21:03:58.972-04:00Comments on Just A Life Sciences Blog...: FDA Should Have Background Materials Up on Asenapine -- Um, Now.Unknownnoreply@blogger.comBlogger6125tag:blogger.com,1999:blog-4241416962008169508.post-36100013416929342302009-07-28T11:16:18.290-04:002009-07-28T11:16:18.290-04:00I know you know this -- but take your time -- we w...I know you know this -- but take your time -- we will wait.<br /><br />It will be worth it, to have the sense of your cogent, but <i>Picean</i>, insights. . . .<br /><br />NamasteCondorhttp://shearlingsplowed.blogspot.comnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-52512159538606478522009-07-28T07:35:26.946-04:002009-07-28T07:35:26.946-04:00It's now 48.5 hours before the meeting and no ...It's now 48.5 hours before the meeting and no background materials.<br /><br />The meeting announcement has this to say:<br /><br />"FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting."<br /><br />Well it seems I should have checked the fine print.<br /><br />It looks like if you really didn't want to give anyone the ability to go over materials you could just release it at the meeting and after. Especially if it's voluminous like the last PDAC background package.<br /><br />That's what they do with the slides although companies get to see the FDA's slides before the meeting but not the other way around.<br /><br />I believe this is another issue for the FDA transparency initiative.<br /><br />SalmonAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-11508973044704243012009-07-27T18:39:22.963-04:002009-07-27T18:39:22.963-04:00Thanks -- as will I.
NamasteThanks -- as will I.<br /><br />NamasteCondorhttp://shearlingsplowed.blogspot.comnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-8826124425525000532009-07-27T18:27:36.060-04:002009-07-27T18:27:36.060-04:00Well the work day is over and no background docume...Well the work day is over and no background documents yet. Actually I'm not surprised the FDA policies state that they will be provided no later than 48 hours before the meeting. Typically FDA releases them in the morning about 49 hours before the meeting.<br /><br />I'll be looking tomorrow morning.<br /><br />SalmonAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-20762213173830916442009-07-27T10:05:15.410-04:002009-07-27T10:05:15.410-04:00"Fishy. . ." Heh!
Perfect!
Thanks agai..."<i>Fishy</i>. . ." Heh!<br /><br />Perfect!<br /><br />Thanks again -- NamasteCondorhttp://shearlingsplowed.blogspot.comnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-50158017941709265722009-07-27T09:33:44.297-04:002009-07-27T09:33:44.297-04:00Thank you.
I was looking over the regulations cov...Thank you.<br /><br />I was looking over the regulations covering FDA release of materials and boy does it allow a lot of hiding things.<br /><br />They can be found under 21 CFR 314.430 and 21 CFR part 20.<br /><br />http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.430<br /><br />http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=20<br /><br />(most of part 20 is irrelevant to this but there are a few tidbits like just because a company calls something confidential or a tradesecret doesn't mean anything.)<br /><br />First they are not laws but rather they are regulations, i.e. FDA decided themselves what they would release.<br /><br />As for the AC materials this is what the regs say:<br /><br />"(d)(1) If the existence of an application or abbreviated application has been publicly disclosed or acknowledged before the agency sends an approval letter to the applicant, no data or information contained in the application or abbreviated application is available for public disclosure before the agency sends an approval letter, but the Commissioner may, in his or her discretion, disclose a summary of selected portions of the safety and effectiveness data that are appropriate for public consideration of a specific pending issue; for example, for consideration of an open session of an FDA advisory committee."<br /><br />It goes on to say the summary may be prepared by the company with sign off by the FDA or by the FDA and of course everybody trusts Fred and Tom Laughren the Psych division director 100%.<br /><br />The summary (SBA) is then required to be released upon approval. From the Drugs@FDA.gov website if you look at SBAs you'll find that they fall into 2 categories 1) a summary written by FDA management b) individual reviews often heavily redacted.<br /><br />Often from the scientific content you can tell that the redaction does not fall under trade or commericial secrets as defined by 314.430 and thus seems to be suspicious.<br /><br />So if we see a summary written by FDA management without individual reviews or without individuals reviews in clinical pharmacology, and pharmacology/toxicology or these reviews are redacted (they shouldn't be at all) then I would say something fishy is going on.<br /><br />And I know fishy.<br /><br />SalmonAnonymousnoreply@blogger.com