Blog

All our Blog posts can be found here, listed in chronological order beginning with the most recent post. To access blogs on specific topics, use the links below.

Publishing an eCTD Clinical Study Report: ICH E3

August 15, 2017 | B J. Witkin, Senior Manager | Regulatory Operations Because IMPACT writes and publishes so many CSRs, we get a lot of sponsors asking us questions about how CSRs should be published. This tells me that there’s a lot of confusion about CSR...

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What Does a Regulatory Medical Writer Do All Day?

August 11, 2016 | Nancy Smith, PhD, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services In my last post, I explored my transition from the bench to regulatory medical writing. I knew little about medical writing when I started, but...

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Top Two Things I Learned at DIA RSIDM

February 18, 2016 | B J. Witkin, Senior Manager | Regulatory Operations I recently attended the DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) forum, an annual conference for people who work in Regulatory Operations and Regulatory...

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Formal Meetings with FDA for Biosimilar Products

February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting Yeah, yeah, we know. The general public considers biosimilars to be “generic” versions of approved biological products. The FDA has gone to...

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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 (SCE), the Integrated...

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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 prescription medications....

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