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Tag Archives: submissions
August 2011 FDA Guidances
Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading
Transitioning from Paper to eCTD Submissions
A common question that many sponsors ask is, “Can we switch a paper application over to eCTD format?” The short answer is, “Yes.” For a more detailed explanation, check out my new guest post over at GlobalSubmit’s blog, The eCTD … Continue reading
Posted in eCTD, FDA, Guest Posts, Regulatory Strategy
Tagged BLA, eCTD, FDA, GlobalSubmit, IND, NDA, submissions
2 Comments
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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Free Webinar – FDA Review Process for eCTD Submissions
Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, 01 March at 3:00 PM ET. Continue reading
Posted in eCTD, Regulatory Strategy, Webinars
Tagged Cato Research, DIA, eCTD, FDA, GlobalSubmit, RAPS, rev, submissions, webinar
2 Comments
Advice from the FDA, Part 1: Technical Errors to Avoid in Your eCTD Submissions
Cato’s Director of Regulatory Operations, Evan Richardson, authored a guest blog post featured on PharmPro.com today. PharmPro.com is the website for Pharmaceutical Processing magazine, offering a wealth of information on products, technologies and applications for pharmaceutical and biopharmaceutical professionals. Evan’s … Continue reading
Posted in eCTD, Guest Posts, Publications, Social Media
Tagged best practices, eCTD, FDA, guest post, PharmPro.com, submissions
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