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Research exemption
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#	Item
701	Microsoft Word - 19Jun2012 BCG Eucomed Final.docx Add to Reading List Source URL: www.eucomed.org Language: English - Date: 2012-09-24 08:04:38 Pharmaceutical sciences Pharmacology Clinical research Pharmaceutical industry Medical device Center for Devices and Radiological Health Investigational Device Exemption Premarket approval Clinical trial Medicine Food and Drug Administration Health
702	C[removed]: REFERRAL TO THE CJEU REGARDING THE SCOPE OF THE BOLAR EXEMPTION The Düsseldorf Court of Appeal has referred questions to the Court of Justice of the European Union (CJEU) regarding the extent to which the Bola Add to Reading List Source URL: www.jakemp.com Language: English - Date: 2014-02-06 10:55:27 Intellectual property law Patent infringement Patent attorney Abbreviated New Drug Application Patent Law Patent law Research exemption
703	AMENDMENTS TO THE UK PATENTS ACT TO EXTEND THE BOLAR EXEMPTION FOR CLINICAL TRIALS Background There is widespread variation across the world in the extent to which conducting clinical trials to assess the safety and effi Add to Reading List Source URL: www.jakemp.com Language: English - Date: 2014-05-23 07:40:28 Research exemption Patent infringement Patent attorney Prior art Patent Drug Price Competition and Patent Term Restoration Act Roche Products v. Bolar Pharmaceutical Supplementary protection certificate Law Patent law Intellectual property law
704	What is an Investigational Device Exemption (IDE)? Lynn Henley SLIDE 1 Hello. My name is Lynn Henley. I represent the IDE Program Office within the Office of Device Evaluation at the Center for Devices and Radiological H Add to Reading List Source URL: www.fda.gov Language: English Health Research Pharmaceutical industry Pharmacology Drug safety Investigational Device Exemption Medicine Food and Drug Administration Clinical research
705	JAMA PATIENT PAGE \| Health Policy FDA Authorization of Medical Devices Similar to drugs, medical devices in the United States go through a review process by the US Food and Drug Administration (FDA) before they can be m Add to Reading List Source URL: jama.jamanetwork.com Language: English Technology Investigational Device Exemption Premarket approval Center for Devices and Radiological Health Medical device Clinical trial Humanitarian Device Exemption Clinical research New Drug Application Food and Drug Administration Medicine Health
706	Emergency Use and Compassionate Use of Unapproved Devices Presented by Fabienne Santel, MD Division of Bioresearch Monitoring Office of Compliance Add to Reading List Source URL: www.fda.gov Language: English Research Pharmaceutical industry Expanded access Investigational Device Exemption Food and Drug Administration Pharmacology Pharmaceutical sciences Clinical research
707	Pt[removed]CFR Ch. I (4–1–12 Edition) (ii) The requirements of paragraphs (g)(3)(ii), (g)(3)(iii), and (g)(3)(iv) of this Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-07-12 15:05:12 Medical device Investigational Device Exemption New Drug Application Federal Food Drug and Cosmetic Act Biologic Premarket approval Center for Devices and Radiological Health Investigational New Drug Center for Biologics Evaluation and Research Food and Drug Administration Medicine Health
708	What is an Investigational Device Exemption (IDE)? Lynn Henley Investigational Device Exemption Program Office of Device Evaluation Center for Devices and Radiological Health Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceutical sciences Pharmaceutical industry Pharmacology Investigational Device Exemption Pharmaceuticals policy Food and Drug Administration Medicine Health
709	Review of the Research Exemption (‘Bolar’) Provision as set down in Section 42(g) of the Patents Act[removed]The Department is inviting comments from interested parties on a proposal to broaden the scope of the “Bola Add to Reading List Source URL: www.djei.ie Language: English - Date: 2012-03-06 09:26:09 Law Patent law of the European Union Intellectual property law Patent law Research exemption Government Supplementary protection certificate European Medicines Agency Directive 2001/83/EC Clinical research Pharmaceuticals policy Research
710	Microsoft Word[removed]doc Add to Reading List Source URL: www.iip.or.jp Language: English - Date: 2009-12-27 21:05:45 Property law Patent Bayh–Dole Act Prior art United States patent law Research exemption Software patent Patent law Law Civil law

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