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2014-09-30 23:23:50

For generic drugmakers, Oct. 1 is crunch time, the date after which all ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments (GDUFA) of 2012. Joan Janulis, a Hatch-Waxman pro and all-around expert on FDA regulation in the generic drug industry, will help attendees read between the lines of the GDUFA performance metrics, associated guidance documents and MAPPs, and provide a roadmap to the post-GDUFA paradigm....

2014-09-30 23:22:05

The custom stainless steel fabrication company will discuss its on-site tank remediation services, bioreactor design and fabrication, pressure vessel parts and other benefits for the life sciences industry. Springfield, Mo. (PRWEB) September 30, 2014 The custom stainless steel fabrication company HOLLOWAY AMERICA will participate at ISPE Boston Product Show 2014. The Boston Area Chapter of ISPE (International Society for Pharmaceutical Engineering) has booked the 23rd annual, day-long...

2014-09-30 23:13:09

Transparency Market Research has published a new report titled "Biological Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020" to its report database. Albany, New York (PRWEB) September 30, 2014 The biological drugs market encompasses a class of medicine that is developed through genetic modification of monoclonal antibodies. Monoclonal antibodies naturally inhabit the human immune system and help the body in fighting from a variety of...

2014-09-30 23:11:13

MarketOptimizer.org adds “Pericarditis Global Clinical Trials Review, H2, 2014” to its store. This report provides elemental information and data relating to the clinical trials on Pericarditis. Dallas, Texas (PRWEB) September 30, 2014 Clinical trial report, “Pericarditis Global Clinical Trials Review, H2, 2014″ provides data on the Pericarditis clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Pericarditis. It includes...

2014-09-30 23:09:52

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced a full agenda for the 25th Annual CPhI Worldwide Exhibition to be held in Paris, France, from October 6th to 9th. Somerset, N.J. (PRWEB) September 30, 2014 Catalent Pharma Solutions (Stand 2C9), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and...

2014-09-30 23:06:10

MarketOptimizer.org adds “Hyperemia Global Clinical Trials Review, H2, 2014” to its store. This report provides elemental information and data relating to the clinical trials on Hyperemia. Dallas, Texas (PRWEB) October 01, 2014 Clinical trial report, “Hyperemia Global Clinical Trials Review, H2, 2014″ provides data on the Hyperemia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Hyperemia. It includes an overview of...

2014-09-30 23:04:46

MarketOptimizer.org adds “Idiopathic (Essential) Hypertension Global Clinical Trials Review, H2, 2014” to its store. This report provides elemental information and data relating to the clinical trials on Idiopathic (Essential) Hypertension. Dallas, Texas (PRWEB) October 01, 2014 Clinical trial report, “Idiopathic (Essential) Hypertension Global Clinical Trials Review, H2, 2014″ provides data on the Idiopathic (Essential) Hypertension clinical trial scenario. This report provides...

2014-09-30 23:03:49

MarketOptimizer.org adds “Occlusive Arterial Disease (OAD) Global Clinical Trials Review, H2, 2014” to its store. This report provides elemental information and data relating to the clinical trials on Occlusive Arterial Disease (OAD). Dallas, Texas (PRWEB) October 01, 2014 Clinical trial report, “Occlusive Arterial Disease (OAD) Global Clinical Trials Review, H2, 2014″ provides data on the Occlusive Arterial Disease (OAD) clinical trial scenario. This report provides elemental...

2014-09-30 20:23:13

OTTAWA, Sept. 30, 2014 /CNW/ - Protecting the health and safety of Canadians is our government's highest priority. Our expectation is that Health Canada uses the appropriate powers and tools at its disposal to help ensure that the drugs Canadians need meet the highest safety and quality standards. To that end, Health Canada has taken decisive action today to stop the import into Canada of all drug products from three plants in India. They are: -- Apotex Pharmachem India Pvt Ltd --...

2014-09-30 20:23:04

? Risk-Based Monitoring Solution Recognized at SCDM Annual Conference ? NEWTOWN, Pa., Sept. 30, 2014 /PRNewswire/ -- BioClinica®, Inc., a leading provider of outsourced clinical trial services and eClinical Solutions, today announced that its Compass technology, a risk-based monitoring solution that improves overall quality in clinical trials, has won the inaugural Society for Clinical Data Management (SCDM) NextGen Technology Innovation (TIA) Award, presented as part of SCDM's 2014 annual...


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