RSS Feed
Search Ask-Cato.com
Tags
adverse events biologics biomarkers biosimilar biotech cancer Cato BioVentures Cato Research CDER clinical investigator clinical research clinical trials CMC conference CROs DIA drug development eCTD efficacy FDA funding GlobalSubmit guidance Health Canada IND in vitro diagnostics manufacturing marketing application medical devices NDA NIH nonclinical research oncology Phase 1 Phase 2 PMA postmarketing protocol safety statistical analysis toxicology transparency vaccines venture capital webinarCategories
- Clinical Trials (55)
- Conferences and Meetings (35)
- eCTD (26)
- FDA (78)
- Guest Posts (5)
- Health Canada (6)
- Industry News (62)
- Project Management (1)
- Publications (7)
- Regulatory Strategy (39)
- Social Media (6)
- Statistics (9)
- Uncategorized (1)
- Venture Capital (10)
- Webinars (24)
Author Archives: Guest Post
Clinical Study Reports to STFs
When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?” To explain the importance … Continue reading
Posted in eCTD, FDA, Guest Posts
Tagged clinical study report, eCTD, EMA, FDA, GlobalSubmit, Health Canada, Japan, STF, study tagging files
Comments Off
Diabetes Research Strategic Plan
The media continually alerts us to the epidemic of diabetes in the world. Diabetes is the seventh leading cause of death. Worldwide in 2007 there were 246 million people diagnosed with diabetes, and an additional 79 million people are at … Continue reading
Posted in Clinical Trials, Industry News
Tagged biomarkers, clinical research, clinical trials, diabetes, guest post, NIH, patient recruitment
Comments Off
How will Healthcare Reform Impact Your Next Investigator Meeting?
The new Healthcare reform legislation can be debated by Americans for days on end, but tucked in among all of the changes for Medicare beneficiaries, pre-existing conditions, and the effects on small business owners lays a provision that most layman would not even notice. This provision, however, has the attention of US drug and device manufacturers and cannot be ignored. Continue reading
Posted in Clinical Trials, Conferences and Meetings, FDA, Industry News, Webinars
Tagged clinical trials, guest post, healthcare reform, HHS, investigator meetings, webinar
Comments Off
Top Reasons to Adopt eCTD Viewing Software
The audience for the eCTD viewer at a drug company ranges from a few users to hundreds or even thousands, depending on the size of the company. Essentially, anyone who writes content, communicates with the FDA, or creates a submission should be using eCTD viewing software. And yet, despite the many advantages and increased global adoption of eCTD submissions, there are still questions and concerns around implementation, in particular among the smaller IND companies. Continue reading
August 2010 FDA Guidances
Image via Wikipedia 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 August 2010 (links go directly to PDF documents). Special … Continue reading
Posted in FDA, Industry News
Comments Off
