Publication – Form FDA 483 – Time to Demystify the Myths and Misunderstandings
Target Health is very pleased to announce that a paper entitled Form FDA 483 – Time to Demystify the Myths and Misunderstandings, authored by Glen Park, Michael Hamrell and Jules Mitchel, has been published by The Society for Clinical Research Sites in their journal InSite. A pdf. copy of the paper can also be found on the Target Health website.
The following is an excerpt from the paper and for sure says it all.
Nobody wants to receive Form FDA 483 after an FDA inspection of a clinical site, drug/device company, manufacturing plant or other entities subject to regulatory inspections. Nevertheless, while inspection findings are inevitable, they are not intended to be the end of the world. This paper will focus on the impact of Form FDA 483 activities associated with clinical investigators.
Check out this scenario! After a new drug application (NDA) is submitted for a novel drug product, a U.S. Food and Drug Administration (FDA) inspector arrives at the door of a clinical research site. As panic sets in, the contract research organization (CRO) and pharmaceutical company sponsoring the study are immediately notified. Everyone, including the principal investigator, chant the following poem in the office cafeteria:
When FDA issues a 483
The hammer comes down, that’s the end of me.
We’re out of business, I lose my job
Get me outta this mess, I pray to God
FDA Limerick by Jules T. Mitchel and Joyce Hays
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ON TARGET is the newsletter of Target Health Inc., a NYC-based, full-service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor