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Canada to Require Evidence of GMP Compliance for Foreign Buildings
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Drugmakers Seek Clarity on FDA’s CMC Draft Guidance
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FDA Finalizes Guidance on When to Register as a Drug Compounder
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Drug Compounders Seek Clarification on FDA’s AE Reporting Guidance
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Managing the Drug Supply Chain: Best Practices
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The New Excipient GMP Standard: A Guide for Drugmakers
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Strategies for Biosimilars Approval: A Map to 351(k) Success
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ICH Recommends Limited Use of Pharmaceutical Solvent
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FDA Sets New Dissolution Specifications for IR Drugs
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AbbVie Steps Up Attack on FDA’s Biosimilars Labeling Approach
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FDA Limits Acetaminophen in Kids’ OTC Liquid Drugs
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ICH Wants More Risk-Benefit Information in CTD Submissions
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