tag:blogger.com,1999:blog-36762711.comments2023-11-03T06:14:58.449-04:00Drug and Device LawRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger1858125tag:blogger.com,1999:blog-36762711.post-60863219323650795862016-05-22T07:11:10.705-04:002016-05-22T07:11:10.705-04:00Very good post! GoogleVery good post! <a href="http://www.google.com" rel="nofollow">Google</a>Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-47798583960493866752016-05-20T13:07:10.256-04:002016-05-20T13:07:10.256-04:00Let me just take this opportunity to thank you aga...Let me just take this opportunity to thank you again for the awesome service you provide. Informative, and entertaining too--hard to beat!Ted Heisenoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-24855648468104141502016-05-19T09:50:53.389-04:002016-05-19T09:50:53.389-04:00Have to recognize that i was looking for such guid...Have to recognize that i was looking for such guidelines for some time now and hopefully your post answered almost all my questions. It's one of the best quest post I've read so far about FDA rules on 3dp explained in a manner that even a newbie in this field can get the ideas. <br /><br />I'm a 3d printing enthusiast myself, enjoying reading helpful blogs as yours. I just want you to continue great job and keep writing more about 3dp. <br /><br />3D print designshttp://www.gambody.com/noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-42783008357110934572016-05-17T12:01:57.648-04:002016-05-17T12:01:57.648-04:00Are you in compliance? BGF Consulting provides FDA...Are you in compliance? BGF Consulting provides FDA regulatory affairs consulting to all regulated industries worldwide. Let us bring you our experience with the <a href="http://bgfconsulting.com/" rel="nofollow">FDA Regulatory Compliance</a> - BGF Consulting, Training and Comments Feed, compliance regulatory, Regulatory compliance and reporting, Regulatory firm, Regulatory Training, regulatory and compliance.Herry Johnsonhttps://www.blogger.com/profile/06336899634205525690noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-17569661336045971492016-05-11T16:05:11.846-04:002016-05-11T16:05:11.846-04:00This is good stuff. It helps everyone in law scho...This is good stuff. It helps everyone in law school really understand what can happen during a trial. And why it's better to win before that has to happen. weltchek mallahanhttp://wmwlawfirm.comnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-47930162731499229882016-04-15T14:06:05.838-04:002016-04-15T14:06:05.838-04:00Biosimilars that are deemed "interchangeable&...Biosimilars that are deemed "interchangeable" with the reference product arguably should enjoy impossibility preemption in the same way that ANDA drugs do. If a biosimilar is interchangeable, states are authorized to permit automatic substitution of the brand drug with the interchangeable biosimilar by pharmacists. But the FDA has not yet enlightened us on the standard for showing interchangeability and it may end up being so onerous to meet that standard that biosimilars manufacturers don't find it worth their while to go that route.Anna Laakmannnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-3086296204893815132016-03-29T13:15:25.357-04:002016-03-29T13:15:25.357-04:00Buy nembutal
Tired of getting scammed , Make you...Buy nembutal <br /><br />Tired of getting scammed , Make you own Nembutal today.<br /><br />Buy Nembutal or other medication online but never receive it because most sellers online are scammers and also because the medicine gets seized by the authorities ? We at Peaceful exit provide end of life choices information . We are the leading end-of-life choices (voluntary euthanasia/ assisted suicide) information & advocacy community. send us an email :infomedsupplies@gmail.comAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-75604650815913129812016-03-26T05:22:07.742-04:002016-03-26T05:22:07.742-04:00Great, discovered your website whilst arbitrarily ...Great, discovered your website whilst arbitrarily dealing with the web seeking some thing entertainment to examine. I an happy to find this fost very useful for me, as it contains lot of information .but i was looking humidity chamber manufacturer. <a href="http://oracleequipments.com/humidity-chamber" rel="nofollow">humidity chamber manufacturer</a> Oracle Equipmentshttps://www.blogger.com/profile/15378613909102691702noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-77100905668072366872016-03-23T15:46:21.197-04:002016-03-23T15:46:21.197-04:00Thanks for the plug. We look forward to seeing yo...Thanks for the plug. We look forward to seeing you and your readers in the Windy City in May.Carter Thompsonhttp://www.bakerdonelson.comnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-33229639133895009212016-03-18T21:22:02.400-04:002016-03-18T21:22:02.400-04:00The brand-name manufacturer made the label and the...The brand-name manufacturer made the label and the generic manufacturer was obliged by law to follow it. The "duty" here is a simple application of basic (i.e., Restatement of Torts, Second) negligent misrepresentation law. One of the key issues in finding a duty is to look at the foreseeability, and these cases are the most "foreseeable" in the land: the brand-name manufacturer of course knows that the label it creates will, by law, be used verbatim on the generic drugs. <br /><br />All this emphasis on <i>the product</i>, i.e., the physical pill itself, is just misdirection. The issue here is <i>the label</i>, and the label came from the brand-name manufacturer. The duty flows right from them to any consumer/physician relying on that label. <br /><br />If you want these cases to go away, go lobby Congress and the FDA to change the rules so that generic manufacturers have the power to submit their own CBEs.Max Kennerlyhttp://www.litigationandtrial.comnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-61916627803135977672016-03-04T13:43:21.120-05:002016-03-04T13:43:21.120-05:00is it bad being a lawyer?
Dui lawyer Arlington Vais it bad being a lawyer?<br /><a href="http://mhhhlawfirm.com/PracticeAreas/DUI-DWI.html" rel="nofollow">Dui lawyer Arlington Va</a>Jr. Williamshttps://www.blogger.com/profile/15627387829300054935noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-23111891987920103762016-03-04T02:56:06.640-05:002016-03-04T02:56:06.640-05:00I really appreciate the kind of topics you post he...I really appreciate the kind of topics you post here. Thanks for sharing information that is actually helpful. Good day!<br /><a href="http://www.ccwlawyers.com/" rel="nofollow">Products Liability</a>Anonymoushttps://www.blogger.com/profile/04368769145610569293noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-43046351197056301022016-02-22T18:55:15.566-05:002016-02-22T18:55:15.566-05:00Interesting post and I ike this website they alway...Interesting post and I ike this website they always put good information !<br />Thank you !Jessicahttp://o-vegas.comnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-88381912947900399972016-02-18T00:25:38.741-05:002016-02-18T00:25:38.741-05:00I feels enlighten reading about your post. The dru...I feels enlighten reading about your post. The drug and device law has a lot of technicalities covered and it's good wrote it as simple as possible for easy reading. Thank you.<br /><br />http://www.goldbachlaw.com/long-beach/medical-leave-lawyer/George Stillerhttp://www.goldbachlaw.com/noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-21359583561992914082016-02-16T09:23:21.726-05:002016-02-16T09:23:21.726-05:00Thank you for your so cool post, it is useful, I l...Thank you for your so cool post, it is useful, I love it very much. 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None of the opinions considered alone has the force of a decision of the court, because no one of them is concurred in by a majority of the Justices; taken collectively, they cannot be regarded as binding upon us in the character of a precedent."<br /><br />City of Dubuque v. Illinois Cent. R. Co., 39 Iowa 56, 79 (1874)Du Ya Jobbnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-52770707384993030312016-01-24T08:01:17.443-05:002016-01-24T08:01:17.443-05:00It seems however that the DEA, via its control of ...It seems however that the DEA, via its control of pharmacist registration, is telling pharmacists that they DO have a duty to monitor patients and to make medical judgements about the "appropriateness" prescriptions patients try to fill. Perhaps the pharmacies will owe a duty to the DEA but not to the patients. Is this an example of conflict between state and federal rights?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-5673508791979739002016-01-22T14:55:31.508-05:002016-01-22T14:55:31.508-05:00That makes no sense -- restrictions on off-label m...That makes no sense -- restrictions on off-label marketing get strict scrutiny but changes to the label get merely rational basis review? The label is the primary means by which manufacturers communicate to physicians. That's like saying a newspaper reporter can say what they want in a TV interview but not write what they want in the actual newspaper. <br /><br />There's really no way around it: given the First Amendment rights claimed by drug companies, the only way it could be "impossible" for a drug company to add a warning is if the FDA proved to a jury that the proposed warning was untruthful and misleading. If a jury finds negligence in failing to warn, they have by definition held that the warning would not be "untrue" or "misleading." Preemption is thus meaningless: it arises only when the plaintiff has lost anyway.Max Kennerlyhttp://www.litigationandtrial.comnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-72971373627704997022016-01-20T22:09:17.167-05:002016-01-20T22:09:17.167-05:00This comment has been removed by a blog administrator.alfredhttps://www.blogger.com/profile/01349478311612577696noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-12896740312644609492016-01-15T23:50:41.172-05:002016-01-15T23:50:41.172-05:00Sorry, but I don't see what the label being tr...Sorry, but I don't see what the label being true has to do with its adequacy as a warning.<br /><br />Say in another context there is a lawn sign "Beware of dog", but the homeowner is also aware of A serious icing risks on the path up to the door. The fact that the dog sign is truthful not at all relevant to whether there should have been notice about the ice. I JUST don't see the first amendment coming into play EITHER WAY IN THAT ANALYSIS,.Soronel Haetirhttps://www.blogger.com/profile/11639906179427371695noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-52870740009327536402016-01-15T12:49:12.768-05:002016-01-15T12:49:12.768-05:00But the government does have a right, and does in ...But the government does have a right, and does in fact, to require prior submission of generic label changes as a reasonable time, place and manner restriction. The impossibility of simultaneous (not eventual) compliance with immediate state-law tort duties is all that is needed for Levine/Mensing/Bartlett preemption.<br /><br />Further, accepting that the speech is both truthful and First Amendment protected will be the end of the case, since tort claims simply cannot be based on protected speech under New York Times v. Sullivan.Bexishttps://www.blogger.com/profile/12984303395998821374noreply@blogger.com