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FDA Completes Initial Review of Millennium & ILEX Partners' BLA Submission for Campath.
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Business Wire; Jun 26, 2000; 700+ Words
...Food and Drug Administration (FDA) related to the partnership...complete response letter, the FDA delineated the deficiencies noted after complete review of the licensing application...R) application satisfied FDA's performance goal for priority...
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CPC of America Completes Initial Trials of Non-Invasive Cardiology Product - Company to Submit Premarket Notification with FDA for CPCA2000(TM) Device -
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PR Newswire; Jul 7, 1998; 700+ Words
...subsidiary has completed initial bench trials of its CPCA2000...Drug Administration (FDA) for clearance to market...diligently work with the FDA in completing the necessary regulatory reviews." CPC of America, Inc...an application to the FDA for marketing clearance...
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FDA completes first steps of its broad initiative to improve regulation of pharmaceutical manufacturing.
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M2 Presswire; Feb 20, 2003; 700+ Words
...February 2003-US FDA: FDA completes first steps of its...Administration (FDA) today announced...accomplished the initial objectives set in...s many critical review and inspection activities...agency's approach to reviews and inspections related...
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FDA completes 1st steps of broad initiative to improve regulation of pharmaceutical manufacturers. (Market Research Studies).
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Biomedical Market Newsletter; Jan 1, 2003; 700+ Words
...Drug Administration (FDA) today announced that it has accomplished the initial objectives set in its...the-art approaches in FDA's many critical review and inspection activities...McClellan, M.D., FDA Commissioner. "These...agency's approach to reviews and inspections related...
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United Therapeutics Successfully Completes FDA Pre-Approval Inspection.
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PR Newswire; Oct 16, 2000; 668 Words
...Inc., successfully completed an FDA Pre-Approval Inspection and that...Office is recommending that the FDA approve the site for manufacturing...conducted in connection with the FDA's review of the initial sections of United Therapeutics...
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FDA test the Food Facility Registration Database.(WASHINGTON)(Food and Drug Administration)
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The Food Institute Report; Oct 30, 2006; 700+ Words
...timely manner. An initial test to verify the...FDA conducted an initial test of 400 randomly...findings from the initial test, FDA recommends...registered facilities to review their data and correct it. After FDA completes the follow-up actions...
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Medical device company details responses to FDA.
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Blood Weekly; Oct 3, 2002; 700+ Words
...CryoLife submitted its initial response to the FDA...CryoLife received its review letter from the FDA...cooperate with the FDA, and adopt the CDC...CryoLife and the FDA have agreed to meet...issues after the FDA completes its review of CryoLife...
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FDA effect of user fees on drug approval times, withdrawals & other agency activities. (Market Research Studies).
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Biomedical Market Newsletter; Oct 31, 2002; 700+ Words
...go through several review cycles before they...example, after its initial review of an application, the FDA may ask the sponsor...information, the FDA undertakes another...OMITTED] Also, if the FDA completes its assessment late...
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King Pharmaceuticals Completes Initial Dosing in Phase I Trial Involving Treatment for Chronic Diabetic Neuropathic Foot Ulcers.
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PR Newswire; Jan 13, 2004; 700+ Words
...the completion of the dosing of the initial concentration of MRE0094 in the Company...Food and Drug Administration ("FDA") review of any Investigational New Drug Application...dependence on our compliance with FDA and other government regulations...
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PHARMOS COMPLETES INITIAL PHASE III TRIAL ON LOTEPREDNOL
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PR Newswire; Jan 18, 1994; 700 Words
...has successfully completed a Food and Drug Administration (FDA) mandated Phase III clinical trial on more than 200 patients...site-active steroid anti- inflammatory drug. A preliminary review of the patient Case Report Forms from this first Giant Papillary...
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Genelabs Completes Submission of New Drug Application to FDA for Lupus Treatment.
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PR Newswire; Sep 26, 2000; 700+ Words
...agreement reached with the FDA, Genelabs used the rolling...has been submitted to FDA for their review, along with the GL701...accordance with U.S. FDA standards (good clinical...of whom experience the initial onset of disease in their...
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CIBA Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics Inc. announce FDA advisory panel recommends approval of Visudyne therapy for wet AMD.
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PR Newswire; Nov 17, 1999; 700+ Words
...case of Visudyne, the FDA did not ask the panel...consideration by the FDA as it completes its review of the New Drug Application...August 16, 1999. The FDA is expected to make a...originally excluded from the initial Phase III investigation...
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CALGENE FRESH COMPLETES PRE-MARKET TESTING ON FLAVR SAVR(TM) TOMATO; DATA SUBMITTED TO FDA AND AVAILABLE TO THE PUBLIC
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PR Newswire; Mar 2, 1993; 700+ Words
...Food and Drug Administration (FDA) for its review and approval. The data demonstrate...responds to questions raised by the FDA during their review of data previously submitted...and sell fresh produce. Its initial product, FLAVR SAVR tomatoes...
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Neoprobe Completes Regulatory Submission for Lymphoseek; Neoprobe Files Chemistry, Manufacturing and Control Response With FDA.
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Business Wire; Apr 11, 2006; 689 Words
...2006. We look forward to FDA's review of the CMC and preclinical...requested permission of FDA to authorize the commencement...evaluate the safety and obtain initial information of the efficacy...to a positive review by FDA of our submissions and...
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[0] DoctorSurf.com Announces the Formation of the First Internet-Based Institutional Review Board; Institutional Review Board Immediately Completes First Review.
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Business Wire; Jun 7, 2000; 700+ Words
...based Institutional Review Board. The IIRB, which reviews phases I through...timely protocol review. The Internet Institutional Review Board is a Central...IIRB conducts the initial and ongoing review...subjects according to FDA regulations and...DoctorSurf.com and ...
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DoctorSurf.com Announces the Formation of the First Internet-Based Institutional Review Board; Institutional Review Board Immediately Completes First Review.
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Business Wire; Jun 7, 2000; 700+ Words
...based Institutional Review Board. The IIRB, which reviews phases I through...timely protocol review. The Internet Institutional Review Board is a Central...IIRB conducts the initial and ongoing review...subjects according to FDA regulations and...DoctorSurf.com and ...
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FDA Advisory Committee Recommends Regulatory Clearance of VITEX's SD Plasma
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PR Newswire; Dec 13, 1996; 700+ Words
...work closely with the FDA to complete the review process and make SD...been transfused since initial product licensure without...expansion at its current FDA licensed manufacturing...Once this new facility completes the FDA inspection process and...
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Mutual recognition, but step by step.
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The BBI Newsletter; Nov 1, 1997; 700+ Words
...for compliance with FDA requirements. Of...to be added as the FDA completes the necessary device...pilot program, the FDA was most cautious...notified bodies to review 510(k)s against...and to submit the reviews to the FDA for final...MRA will run for an initial ...
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U.S. Food and Drug Administration completes review of recycled plastic bottle for Coca-Cola; market introduction to begin in first quarter 1991.
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PR Newswire; Jan 10, 1991; 700+ Words
...DRUG ADMINISTRATION COMPLETES REVIEW OF RECYCLED PLASTIC...quarter of 1991. The FDA action marks the...its review, the FDA said, "We believe...completion of the FDA review, we have...USA. "After the initial introduction, we...
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Akesis Pharmaceuticals Completes Phase IIa Trial of AKP-020 for Type 2 Diabetes.
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Business Wire; Jun 4, 2008; 700+ Words
...results of the original 10-patient trial and the plans for the larger study will be submitted to the FDA for review. "We are encouraged by the initial findings of this Phase IIa trial and we look forward to studying the safety and potential treatment...
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