FDLI.org (food drugs animal-drugs biologics cosmetics diagnostic dietary-supplements medical-devices tobacco academics international ) RSS Feedhttp://www.fdli.orgFDLI.org RSS FeedsCopyright 2013 Food and Drug Law InstituteMedical Device Tax and Innovation: The Last Nail?The current issue of Policy Forum (Volume 3, Number 9, May 22, 2013) – “The Medical Device Tax and Innovation: The Last Nail?” – examines the financial impact of the 2.3% medical device tax passed in 2013 as part of the Affordable Care Act.  Author Gael D. Tisack, Vic...~/resources/resources-order-box-detail-view/medical-device-tax-and-innovation-the-last-nail-5/22/2013 5:27:22 PMTransparency in European Union Clinical Trials: An FDLI Webinar http://www.fdli.org/conferences/conference-pages/transparency-in-european-union-clinical-trials-an-fdli-webinar5/28/2013 2:29:44 PM Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries http://www.fdli.org/conferences/conference-pages/2013-advertising-and-promotion-conference9/16/2013 6:00:53 PM FDLI International Conference: China-US Updates in Food and Drug Law http://www.fdli.org/conferences/conference-pages/fdli-international-conference/overview10/15/2013 5:31:36 PMTobacco Control Act Substantial Equivalence Rebuttal Is Focus of New FDLI Food and Drug Law Policy Forum~/resources/resources-standard-detail-view/tobacco-control-act-substantial-equivalence-rebuttal-is-focus-of-new-fdli-food-and-drug-law-policy-forum4/23/2013 6:15:42 PMIn the Aftermath of Parens Patriae: Can Private Copycats Still Sue?This issue of our Policy Forum (Volume 3, Number 8, April 24, 2013) — In the Aftermath of Parens Patriae: Can Private Copycats Still Sue? — explains that pharmaceutical manufacturers are increasingly subject not only to suits brought by state attorneys general...~/resources/resources-order-box-detail-view/in-the-aftermath-of-parens-patriae-can-private-copycats-still-sue-4/23/2013 5:25:01 PM2013 FDLI Annual Conferencehttp://www.fdli.org/conferences/conference-pages/2013-fdli-annual-conference/overview4/23/2013 1:51:02 PMHow to Comply with cGMPsInstant Access, Purchase and Download Now by Cathy Burgess; Appendix by Neil Di Spirito All pharmaceutical and biologics stakeholders should understand the importance of compliance with and application of current good manufacturing practices (cGMPs) and the legal and regulatory consequence...~/resources/resources-order-box-detail-view/how-to-comply-with-cgmps4/19/2013 8:35:05 PMSubstantial Equivalence Under the Family Smoking Prevention and Tobacco Control Act of 2009: How Can FDA Create a More Effective and Efficient Regulatory Scheme?(A Response to Mark E. Greenwold’s ‘What Standards Should FDA Apply in Ruling on Applications for Substantial Equivalence for Tobacco Products Under the Family Smoking Prevention and Tobacco Control Act of 2009?’ (Volume 2, Issue 18, September 26, 2012)) This issue of Policy F...~/resources/resources-order-box-detail-view/substantial-equivalence-under-the-family-smoking-prevention-and-tobacco-control-act-of-2009-how-can-fda-create-a-more-effective-and-efficient-regulatory-scheme-4/9/2013 5:33:18 PMBringing Your Medical Device to Market, 3rd EditionMedical device companies face extraordinary obstacles to successfully develop and market a medical device. This practical, yet comprehensive, book is now in its third edition and is a must-have tool for guiding medical device manufacturers through the complex process of bringing a new device to m...~/resources/resources-order-box-detail-view/bringing-your-medical-device-to-market-3rd-edition4/9/2013 1:47:52 PM