HeyJaredTim Sandle
- Indexed articles, last 90 days
- 2
- Latest publication
- Oct 1, 2026
- Outlet visibility, for Pharmaceuticalonline
- Top 5M sites
- Earliest in this view
- Sep 1, 2026
Latest articles
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters (opens the original)
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In August 2026, the FDA issued a new draft guidance on container closure systems for human drugs and biological products.1 When finalized, the document is intended to supersede both the FDA’s May 1999 guidance, Container Closure Systems for Packaging Human Drugs and Biologics,2 and the associated May 2002 questions-and-answers guidance.3 The draft is currently available for comment. The proposed revision reflects changes in pharmaceutical products, packaging technology, drug delivery systems, an
FDA Issues New Guidance On Therapeutic Equivalence (opens the original)
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The FDA has issued guidance on the Evaluation of Therapeutic Equivalence,1 clarifying the scientific and regulatory principles that underpin whether one drug product can be substituted for another. The guidance is intended to be considered alongside the publication Approved Drug Products With Therapeutic Equivalence Evaluations (which is commonly known as the Orange Book).2 The nearest European Medicines Agency (EMA) equivalent is the concept paper Product-specific bioequivalence guidance.”3 The
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Top 5M sites
For Pharmaceuticalonline, the outlet · Measured Aug 1, 2026
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