Nonclinical Toxicology Sector Predictions for 2012

Growth in demand for nonclinical toxicology services will be weak for the foreseeable future analysts said after the Society of Toxicology (SOT) annual meeting in San Francisco this past week. كيف تربح في الروليت   “Most agree that the industry is not merely going...

FDA Pre-IND Meetings: Why, When and How

The pre-IND phase of drug development is the foundation upon which all development-related activities (including registration) depend.  It is, therefore, essential to give proper forethought and attention to this initial, all-important step of the drug-development...

Is Pharmaceutical Collaboration an Oxymoron?

With the rise of combination therapy – the use drugs with different mechanisms of action to combat a specific disease state – comes the need to address medical costs and reimbursement issues. مواقع رهان   Joint negotiation of package deals with government and...

New FDA Transparency Impacts Drug Safety

In the FDA’s effort to make both its decisions and clinical trial data more transparent to the public, Agency decisions have become more available for public debate.  Sophisticated analyses (increasingly by third parties) of publically available data may present...

Why is naming a drug so difficult?

In February 2010 the FDA published “Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names” (Guidance), which describes in detail the FDA’s evaluation methodology for proposed proprietary drug names.  By carefully...