Newspaper article from our research archive:
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Arthur Ericsson, M.D.(BIMO/NIDPOE/ORI/OHRP)(Clinical report)
- Article from:
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Warning Letter Bulletin
- Article date:
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June 1, 2008
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Copyright informationCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Houston, TX, March 31 (CDER)
Between March 22 and April 18, FDA conducted an investigation and met with Ericsson to review the conduct of a clinical investigation to evaluate an investigational drug for the therapy of autoimmune/inflammatory conditions involving the nervous system.
FDA believes that Ericsson repeatedly or deliberately violated regulations governing the proper conduct of clinical studies involving investigational products. The agency also noted that in a Warning Letter dated Nov. 17, 1993, FDA informed Ericsson that he violated a clinical hold for another investigational product, failed to maintain adequate records of the disposition of the drug, and ...
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Managing changes during a clinical investigation, Part II: what are the...
Medical Device Technology;
October 1, 2003 ;
Donawa, Maria;
787 words
......manufacturing process, the clinical investigation plan (CIP) or protocol, or...are planned, initiating a clinical investigation after notification, and conducting a clinical investigation. However, there are no specified...
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Safety program builds savings for contractor. (Baker Concrete Construction...
Business Insurance;
December 12, 1994 ;
Schachner, Michael;
370 words
......SHM) Thursday filed its response to clinical hold issues raised by the U.S. Food and...original IND was filed on Aug. 19. A clinical hold was placed on the application 30 days...company's application that details the clinical hold issues, said Kellman. Because of the...
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Lift ED drug's clinical hold, Zonagen asks.(Brief Article)
Medical Marketing & Media;
June 1, 2000 ;
Dickinson, James G.;
79 words
...* Hoping to have a clinical hold on development of its Vasomax and Vasofem lifted, Zonagen says...disorder. The Food and Drug Administration placed the programs on clinical hold last August because preliminary findings from the rat study...
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Successful recruitment for medical device clinical studies.(regulation and...
Medical Device Technology;
October 1, 2004 ;
Donawa, Maria;
787 words
......obstacle during a medical device clinical investigation. It can lead to costly delays and...enrolled and retained throughout the clinical investigation so that scientifically valid conclusions...safety profile. This is because a clinical investigation that does not enrol or retain ...
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FDA Maintains Clinical Hold on Alteon's ED Study of Alagebrium.
PR Newswire;
September 30, 2005 ;
731 words
......Division that it is maintaining the clinical hold previously placed on the Company's...and Urologic Drug Products placed on clinical hold further enrollment in the EMERALD study...data, it has decided to maintain the clinical hold pending further preclinical testing...
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Telik Announces Clinical Hold on TELCYTA Trials.
PR Newswire;
June 5, 2007 ;
598 words
......Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug (IND...TELCYTA(R) (canfosfamide HCl). The clinical hold was initiated by FDA following the...treatment until the FDA releases the clinical hold. Telik plans to submit to the FDA additional...
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Protalex Inc. Announces the FDA'S Lifting of Clinicial Hold.
PR Newswire;
September 12, 2005 ;
441 words
......Administration ( FDA ) has removed the clinical hold on its Investigational New Drug ( IND...FDA placed on the Company's IND on clinical hold pending additional product characterization...filed its official response to the clinical hold issue with the FDA. About Protalex...
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AVAX Provides Regulatory Update.
PR Newswire;
April 23, 2001 ;
765 words
......confirming the previously-reported clinical hold of AVAX's M-Vax and O-Vax autologous...prepare a comprehensive response to the clinical hold inquiries received from the FDA. Given...from the Company. Accordingly, the clinical hold cannot presently be characterized as...
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FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial.
PR Newswire;
December 18, 2006 ;
555 words
......company that it is maintaining its clinical hold on the company's second Phase II trial...formulation development. However, the clinical hold will remain in place until sufficient...over vaccine stability, to resolve the clinical hold imposed by FDA/CBER and to perform...
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FDA ALLOWS CLINICAL STUDIES OF TYSABRI FOR TREATMENT OF MULTIPLE SCLEROSIS...
US Fed News Service, Including US State News;
February 16, 2006 ;
412 words
......announced yesterday that FDA removed the clinical hold on Biogen-IDEC's studies of Tysabri...cases were fatal. The removal of the clinical hold allows patients with MS who were previously...and Answers Regarding Lifting of the Clinical Hold on Tysabri (natalizumab), visit http...
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FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS...
M2 Presswire;
February 17, 2006 ;
449 words
......announced yesterday that FDA removed the clinical hold on Biogen-IDEC's studies of Tysabri...cases were fatal. The removal of the clinical hold allows patients with MS who were previously...and Answers Regarding Lifting of the Clinical Hold on Tysabri (natalizumab) CONTACT: Susan...
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