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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

Warning: Parameter 1 to DOMIT_Parser::dataElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 282

Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::endElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 269

Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Warning: Parameter 1 to DOMIT_Parser::startElement() expected to be a reference, value given in /home/spiritfi/public_html/libraries/domit/xml_saxy_shared.php on line 261

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Most FDA Reviewers Not Told to Meet PDUFA Review Goals, GAO Finds

Meeting specific review goals for drugs and biologics is generally not a criterion in FDA reviewers’ performance plans, according to a Government Accountability Office (GAO) report requested by Congress.
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Last Updated (Tuesday, 30 November 1999 00:00) 18 May 2012

 

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Last Updated (Tuesday, 30 November 1999 00:00) 18 May 2012

FDA Warns Cold Sore Drugmaker as Review of OTC Skin Protectants Continues

The FDA has warned Quadex Pharmaceuticals that its cold sore treatment Viroxyn Professional was never approved as a new drug and does not conform to the formulation and labeling requirements for an OTC cold sore drug.
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Last Updated (Tuesday, 30 November 1999 00:00) 18 May 2012

J&J Unit Tweaks Packaging Line After Imodium Recall

Johnson & Johnson (J&J) subsidiary McNeil Consumer Healthcare is modifying some of its packaging equipment after blister unit tears led to a recall of one lot, 53,892 packages, of diarrhea drug Imodium from wholesalers.
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Last Updated (Tuesday, 30 November 1999 00:00) 18 May 2012

Actavis Launches First Generics of GSK Parkinson’s Drug Requip XL

Actavis is launching generic versions of GlaxoSmithKline’s (GSK) Parkinson’s disease drug Requip XL and believes they are the first in the U.S.
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Last Updated (Tuesday, 30 November 1999 00:00) 18 May 2012

Senate Leader Works to Move User Fees Forward, White House Backs Bill

The White House has thrown its support behind the latest Senate FDA user fee bill, S. 3187, as the chamber starts the first procedural steps to move it to the floor for a vote next week.
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Last Updated (Tuesday, 30 November 1999 00:00) 17 May 2012

Full Issue

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Last Updated (Tuesday, 30 November 1999 00:00) 17 May 2012

Novartis Sees Positive Phase III Data for COPD Candidate

Novartis’ chronic obstructive pulmonary disease (COPD) candidate bested placebo in improving lung function, symptom relief and quality of life in a Phase III trial, setting it up for a 2014 U.S. filing.
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Last Updated (Tuesday, 30 November 1999 00:00) 17 May 2012

Drugmakers Get More Tips on Dose Selection, In Vitro Methods for Biotech Drugs in ICH Guidance Addendum

Drugmakers will see more explanation of the proper nonclinical steps to support safety of clinical trials and marketing applications for biotech drugs in an International Conference on Harmonisation (ICH) guidance addendum, just issued by the FDA.
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Last Updated (Tuesday, 30 November 1999 00:00) 17 May 2012

Prometheus Threatens Biotech Investment, Legal Experts Warn

The Supreme Court’s March ruling in Mayo v. Prometheus could have a chilling effect on venture capital investment in biotech ventures, a group of legal experts said during a Wednesday roundtable sponsored by The George Washington University School of Law and the Biotechnology Industry Organization.
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Last Updated (Tuesday, 30 November 1999 00:00) 17 May 2012

FDA to Review Increased Death Risk for Pfizer’s Zithromax

The FDA is reviewing a study that found patients treated with Pfizer’s antibiotic Zithromax may be at a slightly higher risk for cardiovascular death than those taking amoxicillin, Bayer Healthcare’s Cipro or no drug.
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Last Updated (Tuesday, 30 November 1999 00:00) 17 May 2012

Facebook: Pressuring Users to Become Organ Donors?

Is the new Facebook policy coercive? Art Caplan weighs in on posting your organ donor status for all your Facebook friends to see.
Medscape Business of Medicine
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Last Updated (Tuesday, 30 November 1999 00:00) 17 May 2012

GAO: Doctors should submit more data to get meaningful use money

CMS is taking the recommendation into consideration as it prepares to conduct audits to see whether practices qualify for bonuses.
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Last Updated (Tuesday, 30 November 1999 00:00) 17 May 2012

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