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)
Monthly Archives: June 2010
Women In Bio RTP – Beakers and Beer
Join Cato Research in celebrating the Research Triangle Park’s bioscience community! Women In Bio is once again joining sponsors in the community to celebrate RTP’s bioscience community. Here’s your opportunity to meet and make powerful connections with the leaders in … Continue reading
Free Webinar – Past, Present and Future of REMS: Can We Mitigate With Restraint?
Join Cato Research for a free educational webinar on Thursday, 24 June 2010 at 2:00 PM ET. The webinar, titled Past, Present and Future of REMS: Can We Mitigate With Restraint?, will be presented by Jack Snyder, M.D., J.D., Ph.D., … Continue reading
New Associate Managing Director Named for Cato Research’s San Francisco Office
Cato Research Ltd., a global contract research and development organization, today announced that it has named Dr. Erik Berglund as its new Associate Managing Director of its San Francisco office. Dr. Berglund most recently served as Associate Managing Director of … Continue reading
Posted in Industry News
Comments Off
DIA 2010 – Week in Review
The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location. In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas … Continue reading
Posted in Conferences and Meetings, eCTD, FDA
Tagged adverse events, biomarkers, biotech, cell therapy, clinical development, clinical trials, CMC, comparative effectiveness, data standards, DIA, eCTD, FDA, globalization, in vitro diagnostics, personalized medicine, pharmacokinetics, Phase 1, Phase 2, RPS, study tagging files, transparency
2 Comments
New Draft Guidance on Noninferiority Trials
In March 2010, the FDA issued a draft guidance on the use of noninferiority (NI) trials. While not in final form, this guidance should help sponsors understand the issues the FDA considers when reviewing NI trials. In contrast to statements … Continue reading
Posted in FDA
Tagged clinical trials, efficacy, FDA, guidance, noninferiority trials, statistical analysis
Comments Off
