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How to Make Publishing Clinical Summaries Easier
February 4, 2016 | BJ Witkin, Senior Manager | Regulatory Operations One of the biggest challenges of publishing an NDA, MAA or BLA is dealing with the clinical summaries: the Summary of Clinical Safety (SCS), the Summary of Clinical Efficacy…
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Direct-to-Consumer Advertising of Prescription Drugs
August 20, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs We’ve all seen or heard them – either in popular magazines and newspapers or on television and radio – advertisements directed to us, the consumers of…