How the FDA is Helping the Generic Drug Industry

To help facilitate efficient and successful generic drug application and approval processes, the FDA has published, a Manual of Policies and Procedures (MAPP).  This 11-page ...
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The Pros and Cons of Central IRBs

With the expanding number of human clinical trials and multi-trial sites, the need for organized, fast turn-around, and efficient Institutional Review Board (IRB) processes are ...
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Four Types of Real World Evidence to Use in Drug Development

  In an effort to make drug development more patient centric, the FDA encourages pharma and biotech companies to use real world evidence throughout all clinical trial phases.  ...
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Top Three Indicators that Your Clinical Trial is Performing Well

Tracking clinical trial performance as the study progresses allows you to measure how well it’s going and ultimately, its likelihood of success.  Yet, a clinical trial can have ...
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Bringing OTC Drugs to Market

Over-the-counter (OTC) drugs, products that can be used without a prescriber’s authorization, are developed under the OTC Monograph Process.  This three-phase process was ...
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What You Need to Know About Drug Compounding

Drug Compounding is the process of combining, mixing or altering ingredients to an existing drug to customize a drug to suit the needs of a particular patient.  For example, if ...
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Are Virtual Clinical Trials the Key to Patient-Centric Drug Development?

Patient recruitment and sustained enrollment is absolutely essential to the success of drug development.  However, it’s been shown that nearly 80% of clinical trials fail to ...
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Highlights from the PricewaterhouseCoopers 2017 FDA report

The FDA has hit a 20 year low in the issuance of new federal regulations according to the findings in a new report published by PricewaterhouseCoopers (PwC).  In 2017, we saw ...
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Top 3 Attributes That Make an Excellent Clinical Research Coordinator

In the absence of a good clinical research coordinator (CRC), your trial has an increase chance of failing.  The crucial role of the CRC in facilitating the daily clinical ...
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