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eCTD Tips – Tips, advice, and news about regulatory submissions in eCTD format.Tips, advice, and news about regulatory submissions in eCTD format.
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Tips, advice, and news about regulatory submissions in eCTD format.
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eCTD Tips – Tips, advice, and news about regulatory submissions in eCTD format. | ectdtips.com Reviews
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Tips, advice, and news about regulatory submissions in eCTD format.
New FDA Guidances for February 2015 - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/2015/03/new-fda-guidances-february-2015
Authoring for eCTD – Know the Requirements and Think Like a Reviewer. Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) →. New FDA Guidances for February 2015. By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research. Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Action Letters. 8211; MAPP (CDER). Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies.
New FDA Guidances for April 2015 - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/2015/05/new-fda-guidances-for-april-2015
New FDA Guidances for March 2015. New FDA Guidances for May 2015 →. New FDA Guidances for April 2015. By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research. FDA draft and final guidances, released from CDER, CBER, and CDRH in April 2015, are posted. In addition, upcoming advisory committee meetings to be held in the next couple months are listed below with links to more information. 8211; Final Guidance. 8211; Final Guidance. 8211; Final Guidance. 8211; Draft Guidance. Balancing Premar...
Clinical Trials Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/category/clinical-trials-2
Category Archives: Clinical Trials. New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). New FDA Guidances fo...
guidance Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/tag/guidance
New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Click to share on Pinterest (Opens in new window). By Br...
IND Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/tag/ind
Jump on the Development Safety Update Report (DSUR) Bandwagon! By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Cato Research Canada. If you have an open Investigational New Drug application (IND) then you are all too familiar with the periodic reporting requirements. Many US-based sponsors have opted for the Annual … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Click to share on ...
FDA Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/category/fda
New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Click to share on Pinterest (Opens in new window). By Ha...
safety Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/tag/safety
Jump on the Development Safety Update Report (DSUR) Bandwagon! By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Cato Research Canada. If you have an open Investigational New Drug application (IND) then you are all too familiar with the periodic reporting requirements. Many US-based sponsors have opted for the Annual … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Click to share on ...
Regulatory Strategy Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/category/regulatory-strategy
Category Archives: Regulatory Strategy. New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Cato Research is...
Ask-Cato.com Contributor, Author at Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/author/ask-cato-com-contributor
Author Archives: Ask-Cato.com Contributor. New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). New FDA Guida...
drug development Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/tag/drug-development
Tag Archives: drug development. New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). New FDA Guidances for Ma...
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eCTD Software
Take the next step forward. ECTD Software and Tools. The electronic common technical document. While both the FDA and ICH offer several guidance documents intended to facilitate the transition to eCTD submissions, these resources fail to address many important considerations:. What eCTD regulatory software and tools will your company require, and which software provider(s) can offer a package that suits your needs? Courses are most effective for your esubmissions? Or regulatory submission assistance?
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eCTD Tips – Tips, advice, and news about regulatory submissions in eCTD format.
Transitioning from Paper to eCTD. 10 August 2017 By Evan Richardson. In Tips and Advice. In 2011, I wrote a guest post over at The eCTD Summit about transitioning from paper to eCTD submissions. Surprisingly, much of the advice in that post 6 years ago is still applicable, but the process is even easier today. FDA’s deadline for converting marketing applications. Answers to Your eCTD Questions. 28 July 2017 By Evan Richardson. In Tips and Advice. New Technical Rejection Criteria for Study Data. Scanned d...
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