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Federal Register Notice: FDA sets FY 2013 rate for the backlog fee associated with human generic drugs.[ Price : $8.95]
Purdue asks FDA to require acceptable in vitro and in vivo test results on any generic OxyContin products.[ Price : $8.95]
FDA says two Novo Nordisk NDAs for insulin products under review contain data showing a potential increased risk for cardiovascula...[ Price : $8.95]
Novartis says remediating FDA-cited quality issues at the companys Lincoln, NE manufacturing facility is taking longer than expect...[ Price : $8.95]
FDA clears an Osseon Therapeutics 510(k) for its Osseoflex SB steerable inflatable bone tamp for use in treating vertebral compres...[ Price : $8.95]
FDA medical reviewers say it is difficult to give a definitive quantitative analysis of the abuse potential for hydrocodone combin...[ Price : $8.95]
Federal Register Notice: FDA announces the rates for ANDA, Prior Approval Supplement, and Drug Master File fees for fiscal year 20...[ Price : $8.95]
The Senate HELP Committee requests large numbers of documents from FDA, New England Compounding Center, and the Massachusetts Phar...