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Journal Abstract Search
349 related items for PubMed ID: 21537038
21. Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule. Fed Regist; 1998 Apr 10; 63(69):17744-71. PubMed ID: 10177764 [Abstract] [Full Text] [Related]
25. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform. Rossen BR. Food Drug Law J; 2009 Aug 10; 64(1):183-223. PubMed ID: 19998746 [Abstract] [Full Text] [Related]
26. New office and new leader aim to streamline FDA cancer drug review process. Twombly R. J Natl Cancer Inst; 2005 May 18; 97(10):708-9. PubMed ID: 15900036 [No Abstract] [Full Text] [Related]
29. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) perspective on cardiovascular Polypill: A multidimensional concept. Mogielnicki M, Swieczkowski D, Bachorski W, Zuk G, Gilis-Malinowska N, Zarzeka A, Merks P, Gruchala M, Jaguszewski M. Cardiol J; 2016 May 18; 23(5):515-517. PubMed ID: 27723064 [No Abstract] [Full Text] [Related]
31. [New drugs and European procedures of approval. The European Agency for the Evaluation of Medicinal Products' role]. Ainsworth MA. Ugeskr Laeger; 2003 Apr 14; 165(16):1648-9. PubMed ID: 12756819 [Abstract] [Full Text] [Related]
34. The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology. McKee AE, Farrell AT, Pazdur R, Woodcock J. Oncologist; 2010 Apr 14; 15 Suppl 1():13-8. PubMed ID: 20237212 [Abstract] [Full Text] [Related]
37. When EMA and FDA decisions conflict: differences in patients or in regulation? Wolfe SM. BMJ; 2013 Aug 21; 347():f5140. PubMed ID: 23970394 [No Abstract] [Full Text] [Related]
40. [Off-label use in oncology. The Italian choice]. Felicetti V, Gremigni U, Cifaldi L. Recenti Prog Med; 2008 Dec 21; 99(12):612-5. PubMed ID: 19388222 [Abstract] [Full Text] [Related] Page: [Previous] [Next] [New Search]