FDA Law
JANUARY 4, 2023
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contrÂÂols (CMC).
FDA Law
JANUARY 5, 2022
Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.
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FDA Law
JANUARY 5, 2022
Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.
FDA Law
OCTOBER 10, 2023
In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. We find that this information is noteworthy for manufacturers to consider.
GeriPal
MAY 5, 2022
My great-grandmother in particular had a very profound hearing loss and I don’t know, as a kid, I was obsessed with taking them apart and wanted to do more of the engineering side. And honestly in undergrad I was like, “Engineering is really hard. Hearing aids, you had six big manufacturers of hearing aids.
FDA Law
SEPTEMBER 16, 2022
The Executive Order also mentions the need to develop genetic engineering technologies and techniques and advance the science of scale-up production so that innovative technologies and products can reach markets faster. We’ve only touched on a few of the objectives identified in this ambitious and all-encompassing order.
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