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Drugmakers Raise Concerns About CMC Draft Guidance
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Lupin Expands U.S. Generics Presence Via $880M Gavis Deal
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Allergan’s Paragraph IV ANDA for Tyvaso Triggers Lawsuit
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GPhA Names Chester ‘Chip’ Davis Jr. as New President
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Mallinckrodt Loses Lawsuit Against FDA Over ADHD Drug
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Hikma Buying Boehringer Ingelheim’s Generics Unit
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Teva Snaps Up Allergan’s Generics Division for $40.5B
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European Commission Bans Generics Due to Flawed Studies
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FDA Requires Six-Month Notice for Potential Manufacturing Stoppages
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Hospira, Teva, Mylan and Baxter Recalls Pile Up
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Gleevec Purchasers Call Novartis’ Patent Infringement Suit a Sham
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FDA Releases 43 New Guidances on Product-Specific Bioequivalence
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