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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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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What's the Difference Between an Umbrella Study and a Basket Study?

New methods of clinical trial design are thought to allow more patients to participate and test new treatments at a faster rate.  Two relatively new types of studies for cancer ...
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How the Industry Can Help With New FDA Guidance on Generic Drug Development

In order to facilitate timely access to high quality, affordable generic medicines, the FDA has implemented two drug program enhancements with the goal of improving ...
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Why 2017 Was Such a Big Year for Drug Approvals

Even though 2016 was an unusually slow year for FDA drug approvals, in 2017 the number of new drugs sent to market more than doubled.  Forty-six drugs, to be precise, passed ...
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Beyond Labeling: How the FDA Ensures Drug Safety

In 2007, a new law was passed that gave the FDA new authorities and responsibilities to enhance drug safety. It's called the Food and Drug Administration Amendments Act and one ...
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The Who, What, Why, When and How for Registering New Drugs

In the US, there are registration and listing requirements for new drugs going into clinical trials and the companies that manufacture these drugs.  Do you know if these ...
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