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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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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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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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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Newly Launched FDA Pilot Program Includes Data Sharing

A new FDA pilot program, which allows clinical study result information to be posted on their website, has some worried that an agency who once resisted sharing data and left ...
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Is Adaptive Trial Design the Buzzword of 2018 or the Real Deal?

There is always a degree of uncertainty when designing your clinical trial.  What doses should you test? What is the best population and size of population to study?  ...
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What's New in the Updated FDA Guidance on Electronic Records and Signatures

In June of 2017, the FDA released an updated guidance for clinical investigators, and any other associated parties, that use electronic records and signatures in their drug ...
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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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