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Examples
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CPSI Achieves "Approvable" Status from the Ohio Board of Pharmacy for CPOE, E-MAR and Pharmacy Applications
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Approvable letters ask drug companies to conduct more studies to collect additional data on drugs under consideration for FDA approval.
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Non-Approvable Letter for Sugammadex The Food and Drug Administration said it isn't ready to approve a Schering-Plough drug designed to undo the affects of muscle relaxants after surgeries.
Hardly Working 2008
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'Not Approvable' Letter From FDA Eisai Co. received a not approvable letter from the Food and Drug Administration for its proposed sedative, but the company said it would work with regulators to gain approval.
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Non-Approvable Letter for Sugammadex The Food and Drug Administration said it isn't ready to approve a Schering-Plough drug designed to undo the affects of muscle relaxants after surgeries.
Grinding Gears 2008
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But I did some digging on this "Minor Deficiency letter," and it seems that this is equivalent to the "Approvable letter" from the FDA's system up until 2008
Misunderstood News Offers Opportunity for Deep Discount on Momenta Pharmaceuticals - Seeking Alpha 2011
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But I did some digging on this "Minor Deficiency letter," and it seems that this is equivalent to the "Approvable letter" from the FDA's system up until 2008
Misunderstood News Offers Opportunity for Deep Discount on Momenta Pharmaceuticals - Seeking Alpha 2011
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With the receipt of the Approvable Letter from the FDA, one of the final steps in the approval process is the satisfactory completion of a quality system inspection by the FDA at Waldemar LINK GmbH & Co. KG.
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NEW YORK - (Business Wire) Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone & joint sector of the orthopedics industry, announced today that an 'Approvable Letter' has been received from the U.S.
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The Approvable Letter states that the FDA has concluded its review of the S.T.A.R. Ankle PMA application.
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