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Author Archives: Leo DiNapoli
FDA Reorganizes Oncology and Hematology Divisions
When we are no longer able to change a situation, we are challenged to change ourselves. Victor Frankl The FDA recently announced that it is reorganizing three divisions (Hematology Products, Drug Oncology Products, and Biologic Oncology Products) from the Office … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged CDER, FDA, hematology, marketing application, oncology, toxicology, tumors
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Annual Reports: A Time for Reflection
You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year? Quite possibly. In the rush to keep things moving, it’s all too easy to not take the time … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged 21 CFR, adverse events, annual report, clinical trials, CMC, drug development, eCTD, FDA, IND, nonclinical research, protocol
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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
1 Comment
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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