News & Insights
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…
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. …
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…
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…
Concern of blood clot issues with the AstraZeneca and J&J vaccines
https://news.yahoo.com/clear-between-astrazeneca-vaccine-rare-115707510.html https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine https://www.healthline.com/health-news/johnson-johnson-covid-19-vaccine-side-effects-what-to-knowThe articles…
Tips on Using ClinicalTrials.gov 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…
Overview of FDA timelines associated with Traditional 510(k)s
Introduction The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees are intended to be used by FDA on the resources needed to support the review of marking…
Medical Device Breakthrough Designation
With Centers for Medicare and Medicaid Services (CMS) now offering an add-on payment route for breakthrough designated medical devices, it is anticipated that more companies will be submitting requests to FDA for breakthrough designation status. To qualify for breakthrough designation as defined in…