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Tag Archives: ANDA
New Guidances from FDA – May 2011
Here’s a list of the guidances released by FDA in May 2011 (along with a couple that were released inthe first week of June), compiled by Cato Research Regulatory Scientist Cathy Anderson. Commercially Distributed In Vitro Diagnostic Products Labeled for … Continue reading
Posted in FDA
Tagged ANDA, clinical investigator, FDA, financial disclosure, guidance, in vitro diagnostics, labeling, medical devices, submissions
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New FDA Guidances – February 2011
Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in February 2011 (links go directly to PDF documents). Clinical Pharmacogenomics: Premarketing Evaluation … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged ANDA, cell therapy, clinical trials, FDA, guidance, NDA, REMS, safety
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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
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Drug/Biologic/Device Highlights from the Health Care Reform Bill
Cautious, careful people, always casting about to preserve their reputations… can never effect a reform. – Susan B. Anthony Last month, the company behind the FDA Law Blog, Hyman, Phelps & McNamara, P.C., prepared a memo that outlines the provisions … Continue reading
