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Featured Product In Regulatory Affairs

FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
If you want to pass your next inspection, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions is a must. Read More

Regulatory Affairs

Canada: New Premarket Requirements Aimed at Reducing Medication Errors

$40.00
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Industry: Plan to Expand Off-Label Uses in France Undermines EU Regulation

$40.00
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Irish Authority Deems 12 Active Substances Safe for OTC Use

$40.00
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Ombudsman Clears EMA in Rejection of Over-the-Counter Migraine Drug

$40.00
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Adoption of GPvP Guidelines Puts Australia in Line with EU Practice

$40.00
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EMA Manual Explains Ins and Outs of New Pharmacovigilance System

$40.00
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Japan’s PMDA Clarifies Requirements for Companion Diagnostic PMAs

$40.00
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FDA 4-Year Plan to Spur Increase in Global Regulatory Partnerships

$40.00
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Guidance: CDx Sponsors Should Meet Early With FDA on Submission Type

$25.00
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Japan Clarifies Requirements for Companion Diagnostics

$25.00
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Smart Labeling Self-Audits: Prescriptions for Global Regulatory Compliance

$397.00
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Cut Drug Approval Time with a 505(b)(2)

$397.00
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