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Drug or Device? How the 21st Century Cures Act Impacts Combination Products
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Drugmaker’s Guide to the 21st Century Cures Act: Changing the Face of Pharmaceutical and Biologics Regulation
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Special Protocol Assessment: Winning FDA Support for Trial Design
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Adding Pediatric Studies to New Drug Development: A Guide to US and EU Rules
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Pre-Approval Inspection: Four Steps to Success
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$177.00
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Navigating HCT/P Regulations: Risks and Opportunities for Drug and Device Manufacturers
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$397.00
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Achieving ANDA Success: Working with the FDA to Win First-Cycle Approval
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$397.00
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Pharmacovigilance in the European Union: A Guide to New Directives
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$397.00
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Amgen Looks to Replicate Humira, Files Biosimilar Application With FDA
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Analysis Shows FDA Approvals for Generics Rising Year-Over Year
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Japan’s Sakigake Approval Pathway Aims to Cut Drug Lag, Expert Says
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Hospira Prepares Second Biosimilar Application After FDA Rejects First
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