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)
Tag Archives: clinical research
Biotech Funding: Still Playing Hard-to-Get
After a few lean years, biotechs raised $25 billion in 2010. For the majority of small companies however, funding remains difficult to find. Ernst & Young’s annual report on the biotechnology industry, Beyond Borders, was recently released and it paints … Continue reading
Posted in Clinical Trials, Industry News, Venture Capital
Tagged biotech, Cato BioVentures, clinical research, clinical trials, drug development, funding, nonclinical research, Orphan Drug Designations, R&D
Comments Off
Is FDA Issuing More Refuse-to-File Letters?
The June 2011 issue of Nature Reviews: Drug Discovery (volume 10, page 403) includes an interesting news brief regarding the apparent increase in Refuse-to-File (RTF) letters being issued by FDA in recent years. In a review of publicly available … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged Cato Research, clinical research, CMC, eCTD, FDA, IND, NDA, refusal to file
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
Google Insights – A Tool for Smarter Clinical Site Selection
Every year, epidemics of the seasonal flu cause major health concerns and numerous deaths around the world. Vaccines are made in massive quantities and extra precautions are taken, such as hand washing of children in schools, in an effort to … Continue reading
Posted in Clinical Trials
Tagged clinical investigator, clinical research, clinical trials, patient recruitment, site selection, vaccines
Comments Off
