Regulatory Perspectives

Regulatory Perspectives

In this Blog, the reader will find insightful comments about recent developments within the Regulatory community to address the current SARS-CoV-2 pandemic, as well as other pressing regulatory topics. Postings on this blog will focus on discovery/science news to the extent that the subject supports regulatory issues.  We would like to provide a forum for discussion to help all the efforts in the industry to face the crises of our times.


Vaccine Supply: Shortages and Challenges

Apr 26, 2021
By Kevin J. Gilligan Ph.D., Senior Consultant

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Biologics
COVID-19 vaccines

Concern of blood clot issues with the AstraZeneca and J&J vaccines

Apr 23, 2021
By Kevin J. Gilligan Ph.D., Senior Consultant

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Biologics
blood clots coronavirus COVID-19 EMA FDA serious adverse events vaccines

Essential Performance: A Short Story

Apr 20, 2021
By Jennifer Moyer, M.A., M.S., Consultant - Medical Devices

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Medical Device
60601 80601 efficacy IEC ISO performance safety

Tips on Using ClinicalTrials.gov to Align Your Product Clinical Trial Designs with FDA expectations

Feb 23, 2021
By Mark Thornton, MD, MPH, PhD; Senior Clinical Consultant

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Compliance
clinical trials FDA FDA Compliance pivotal trials

Overview of FDA timelines associated with Traditional 510(k)s

Jan 22, 2021
By Becky Ditty, Consultant

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Medical Device
510(k) acceptance AI FDA MDUFMA performance review RTA substantial equivalence substantive timeline traditional

What is Drug Development Tool Qualification? Is it Part of the Critical Path?

Jan 13, 2021
By Christopher Scull, Senior Consultant

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Other
FDA Innovation Qualification Regulatory