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Welcome to FDAweb Pay Per View Search our 45,634 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   FDA Partially Grants Petition on Glycoprotein Inhibitors [230 Words] [ Price : $7.95] FDA partially grants a citizen petition requesting labeling revisions for glycoprotein Ilb/IIIa inhibitors to reflect adverse event risks when the drugs are used for acute coronary syndrome in women. 05/06/2013     Firm Cited for Promoting Investigational Drug on Web Site [329 Words] [ Price : $7.95] FDA cites a CBA Research Web for “misleadingly” promoting the investigational drug CBT-1 (tetrandrine) capsules as safe and effective for uses under investigation. 05/06/2013     Alexion Responds to FDA-483 Inspection Findings [319 Words] [ Price : $7.95] Alexion says it will revise an SOP on “Bioburden Microbial Risk Management & Assessment” based on an FDA inspection finding that it had inadequately investigated microbiological contamination events. 05/06/2013     FDA Safety Alert on Anti-seizure Drugs and Pregnancy Use [274 Words] [ Price : $7.95] A new FDA drug safety alert says the anti-seizure drug valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for preventing migraine headaches. 05/06/2013     CDRH Seeks eSubmissions for Voluntary Complaints [167 Words] [ Price : $7.95] CDRH proposes to establish an electronic submission format and process for voluntary complaints on actual or potential medical device health risk concerns. 05/03/2013     BMS Gains sNDA Approval for Sustiva [199 Words] [ Price : $7.95] FDA approves a Bristol-Myers Squibb supplemental NDA for Sustiva (efavirenz) for dosing recommendations for HIV-1 infected pediatric patients three months to three years old. 05/03/2013     FDA, Chinese Regulators Solidify Working Relationship [440 Words] [ Price : $7.95] FDA says it believes its relationship with Chinese regulatory officials has “matured significantly” since its 2007 outreach began after a wave of product problems coming out of that country. 05/03/2013     Quotient Bio Field Correction on Screening Cells [108 Words] [ Price : $7.95] Quotient Biodiagnostics initiates a field correction involving one lot of Albacyte Antibody Screening Cells due to labeling issue. 05/03/2013     FDA Approves Merck’s Liptruzet for Lowering Cholesterol [140 Words] [ Price : $7.95] FDA approves a Merck NDA for Liptruzet (ezetimibe and atorvastatin) tablets for treating elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia. 05/03/2013     FDA Panel Backs Allergan’s Juvedem Voluma XC [158 Words] [ Price : $7.95] FDA’s General and Plastic Surgery Devices Panel votes unanimously that Allergan’s Juvederm Voluma XC has a favorable benefit-risk profile. 05/03/2013     << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

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