Articles in this Issue

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  Scouting Report

  December 06, 2022
  When my daughter signed up for Scouts (formerly Boy Scouts of America), I was reminded of the motto I memorized when I was a member: Be Prepared. That phrase is especially relevant to companies considering US Food & Drug Agency (FDA) regulations and... read more
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  Solid Dose, High Potency, and High Stakes: The Trends Driving the Growth of the HPAPI Market

  December 06, 2022
  Developing high-potency, high-performance drugs is hazardous, and the stakes are high for investors, the pipeline, and patients. This class of drugs—known as HPAPIs for short—represents a substantial and growing piece of the solid dose pie. But ... read more
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  Preparing for an FDA Inspection? Expect the Unexpected

  December 06, 2022
  An FDA inspection can be one of the most stressful parts of doing business. And while drug pre-approval and pre-license inspections—and most foreign facility inspections are generally pre-announced—FDA does not pre-announce “for cause” and routine ... read more
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  Advice from the Inspectors: An FDA Q&A*

  December 06, 2022
  How can a company best prepare for an FDA inspection? read more
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  Regulatory Review: Top Five Hurdles for FDA ANDA Submissions and Approvals

  December 06, 2022
  The Generic Drug User Fees Amendment III (GDUFA III) program administered by the FDA Office of Generic Drugs has many promises in the making to approve quality generic drugs for the American public. The GDUFA III program, which commenced in October ’... read more
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  An FDA Inspection Tool Kit: What to Expect When Being Inspected

  December 06, 2022
  A list of resources to help prepare for an FDA inspection. read more