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FDA Seeks to Help Generics Obtain REMS-Protected Product Samples
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OGD to Focus on Approvals in Addressing ANDA Backlog
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European Biosimilars Makers Weigh in on Latest Draft Guidelines
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GPhA Unveils Compromise Language for Biosimilar Substitution Laws
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ANDA Backlog, OPQ, Abuse-Deterrent Opioids Among Top CDER Priorities
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Generics Poised for New Realities and New Scrutiny in 2015
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FDA’s Office of Pharmaceutical Quality Revs Up Process to Accelerate ANDA Reviews
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FDA Outlines Clinical Pharmacology Considerations in Pediatric Trials
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India Issues Ream of Clinical Trial Regulations at Year End
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FDA Updates Guide on Clinical Study Data eSubmissions
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Ebola Vaccine Developers Protected From Liability Under U.S. Law
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EFPIA Proposes Process for Early Resolution of Patent Disputes
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