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Tag Archives: PMA
Divisive Devices or UFC 510(k): FDA Meets IOM
In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices. This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, clinical trials, FDA, manufacturing, medical devices, PMA, postmarketing, safety
1 Comment
New FDA Guidances Released in July 2011
Here’s a list of the guidances released by FDA in July 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device In Vitro Companion Diagnostic … Continue reading
New Guidances from FDA – June 2011
Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biologics, cancer, Cato Research, FDA, guidance, IDE, in vitro diagnostics, manufacturing, medical devices, OTC, PMA
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New FDA Guidances – April 2011
Once again, Cato Research Regulatory Scientist Cathy Anderson has compiled a list of the notable guidance documents that have been recently released by the FDA. Here’s a summary of the guidances released in April 2011 (most links go directly to … Continue reading
Posted in FDA, Industry News
Tagged FDA, guidance, humanitarian device exemption, manufacturing, medical devices, PMA, safety, validation
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FDA Ups the Ante on Transparency
Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s … Continue reading
Posted in FDA, Industry News
Tagged 510(k), ANADA, ANDA, biologics, BLA, drugs, exclusivity, FDA, medical devices, NADA, NDA, patent, PMA, transparency
2 Comments
