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Author Archives: LeoDiNapoli
CDRH Proposes Changes to the 510(k) Pathway
All for one, one for all, that is our device. – Alexandre Dumas The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, FDA, guidance, medical devices
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Accelerated Approval
Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics: … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged accelerated approval, clinical benefit, DDMAC, efficacy, FDA, postmarketing, safety, surrogate endpoint
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Safety Data and Transparency
For the safety of all the public, for the safety of our officers, we need to understand intimately all that can be learned – William Bratton You may have noticed that transparency has been a topic of interest lately (for … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged clinical trials, FDA, safety, transparency
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Generic Lovenox – Moving One Step Closer to Biosimilars
We bleed from similar veins. – Tupac Shakur Lovenox is not, I repeat, not a biologic therapeutic. It is derived from a biological source (pig intestines, yum), but it is not protein-based. However, the FDA’s approval of a generic form … Continue reading
Posted in FDA, Industry News
Tagged biologics, biosimilar, drug development, FDA, generic drugs
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HHS Proposes Changes to HIPAA
Image via Wikipedia Privacy is not something that I’m merely entitled to; it’s an absolute prerequisite. – Marlon Brando On July 8th, the Department of Health and Human Services (HHS) announced that it was proposing changes to Health Insurance Portability … Continue reading
