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Consent Decree Payments May be Tax-Deductible, IRS Says
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FDA Pulls Ondansetron NDA, ANDAs Over Safety Concerns
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FDA’s Updated REMS Website Allows for Downloading, Filtered Searches
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Generics Should Mimic Brand Counterparts, FDA says
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FDA, Generics Makers Seek Faster GDUFA Approvals
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Four Biosimilar Guidances Due Out This Year, FDA Official Says
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FDA Clarifies When to Report Postapproval CMC Changes
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Lawmakers Take Aim at Rise in Generic Drug Prices
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Woodcock: US-Europe Mutual Inspection Program a Priority
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UK: Data Integrity Issues Fuel Rise in Critical Inspection Findings
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European Commission Planning Major Revisions to Drug GMPs
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AbbVie Petitions FDA to Set Clear, Transparent Biosimilar Labeling
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