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January 4, 2023  •  Blog

Tips for working with the FDA eStar form

Tips and tricks for navigating the FDA Center for Devices and Radiological Health (CDRH) electronic Submission Template And Resource (eSTAR)

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November 17, 2022  •  Blog

Connected Medical Devices and Public Cloud Services

Public cloud computing services are being increasingly used by medical device manufacturers to house components of medical device software. In this post, I am referring to a public cloud as defined by NIST SP 800-145:2011, The NIST Definition of Cloud Computing, and their “platform-as-a-service (PaaS)”…

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January 28, 2022  •  Blog

The Right CMC Consultant Can Save You Time and Money

You are developing a new pharmaceutical product and think you would benefit from the services of a consultant with expertise in the Chemistry, Manufacturing, and Controls (CMC) requirements of global pharmaceutical regulatory bodies, but you also need to make the most of your CMC budget. Although CMC…

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November 8, 2021  •  Blog

FDA Resumes Medical Device Inspections – What now?

FDA Resumes Medical Device Inspections It is much more likely that you noticed changes to what the FDA has been doing during the COVID-19 pandemic rather than changes to what it has not been doing.  One example of what they have been doing is the review and issuance of Emergency Use Authorizations. …

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September 21, 2021  •  Blog

Human Challenge Studies for Vaccine Development: Regulatory Aspects of Human Challenge Studies

Introduction The traditional regulatory pathway for the evaluation of new vaccine candidates generally proceeds from preclinical through three successive phases of human trials. Study phases may overlap, and the clinical testing may be highly iterative because multiple Phase 1 or 2 trials may need to…

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September 8, 2021  •  Blog

What Should the Public Know About Implantable Material and Device Innovation in the US?

Abstract Device innovation has potential to improve patient outcomes over time, yet prospective benefits must be considered in light of risks. At the macro level, designers and manufacturers of implantable devices and regulators must balance the need for assurance of devices' safety and effectiveness…

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April 26, 2021  •  Blog

Vaccine Supply: Shortages and Challenges The article linked to above provides an excellent overview of the status and rollout of US COVID-19 vaccines and explains some of the technical and organizational challenges…

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April 23, 2021  •  Blog

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

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April 20, 2021  •  Blog

Essential Performance: A Short Story

Why should you care about Essential Performance? Essential performance are equipment specifications that, if one or more fail to be achieved during intended use, the result is the risk of patient harm. If you do not define the essential performance of your product you will not be able to fully claim…

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February 23, 2021  •  Blog

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

One of the Clinical areas in which we at Biologics Consulting are asked to consult involves assisting a company that is planning clinical trials for their product and wishes to do so with minimal risk of failure. In the oncology clinical development space especially, the pace of change can result in…

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