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Category Archives: FDA
The CED Life Science Conference and Biotech’s Yellow Brick Road
The 21st annual CED Life Science Conference achieved its mission of cementing the Research Triangle Park as a hotbed for innovation and opportunity in biotech. The 2012 CED LSC showcased local leaders like Victor Dzau, President and CEO of Duke … Continue reading
Posted in Clinical Trials, Conferences and Meetings, FDA, Industry News, Regulatory Strategy
Tagged adaptive design, adaptive trials, biomarkers, biotech, blockbuster drug, CED, clinical development, clinical trials, drug development, drug industry, FDA, funding, gene therapy, medical devices, Medtronic, molecular biology, postmarketing, regulatory strategy, sanofi-aventis, venture capital
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New FDA Guidances – December 2011/January 2012
Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be … Continue reading
Posted in FDA
Tagged 510(k), biomarkers, CDRH, eCTD, FDA, guidance, IDE, in vitro diagnostics, IND, manufacturing, medical devices, off label promotion, PDF, safety, vaccines
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FDA Issues New PDF Specifications
In the chaos of the holidays, you might have missed the release of an important new guidance from FDA. On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at the … Continue reading
Pre-IND Submissions in eCTD Format
Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes the IND … Continue reading
New FDA Guidances – September 2011
Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Reproductive and Developmental Toxicities – Integrating Study Results to Assess Concerns User Fee Waivers, Reductions, and Refunds for Drug … Continue reading
Posted in FDA, Regulatory Strategy
Tagged FDA, guidance, marketing, toxicology, validation
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