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: Ask-Cato.com Contributor
After all the talk, where are we with biosimilars?
In this highly charged political climate, no news broadcast is complete without some mention of healthcare. Frequently the focus is on healthcare costs, which is one reason that the government charged the FDA in 2010 with creating the 351(k) approval … Continue reading
Posted in FDA, Industry News
Tagged biologics, biosimilar, clinical trials, EU, FDA, follow-on biologics, gene therapy, generic drugs, guidance, healthcare reform, IND, nonclinical research, pre-IND
1 Comment
The CED Life Science Conference and Biotech’s Yellow Brick Road
The 21st annual CED Life Science Conference achieved its mission of cementing the Research Triangle Park as a hotbed for innovation and opportunity in biotech. The 2012 CED LSC showcased local leaders like Victor Dzau, President and CEO of Duke … Continue reading
Posted in Clinical Trials, Conferences and Meetings, FDA, Industry News, Regulatory Strategy
Tagged adaptive design, adaptive trials, biomarkers, biotech, blockbuster drug, CED, clinical development, clinical trials, drug development, drug industry, FDA, funding, gene therapy, medical devices, Medtronic, molecular biology, postmarketing, regulatory strategy, sanofi-aventis, venture capital
1 Comment
New FDA Guidances – December 2011/January 2012
Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be … Continue reading
Posted in FDA
Tagged 510(k), biomarkers, CDRH, eCTD, FDA, guidance, IDE, in vitro diagnostics, IND, manufacturing, medical devices, off label promotion, PDF, safety, vaccines
Comments Off
Fifth China Medicinal Biotech Forum – Conference Recap
I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011. The purpose of this conference was to update graduate students in China on the latest trends in biotechnology. This forum also allowed … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biologics, biosimilar, biotech, China, clinical research, clinical trials, conference, DNA, efficacy, FDA, gene therapy, immuno, manufacturing, monoclonal antibody therapy, NIH, Phase 1, recombinant proteins, safety
Comments Off
Project Management for Biotech Companies
In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to … Continue reading
Posted in Clinical Trials, Project Management, Regulatory Strategy
Tagged biotech, Cato Research, central labs, clinical investigator, clinical research, clinical trials, CMC, CROs, drug development, drug product, efficacy, enrollment, FDA, GCP, GLP, GMP, ICH, manufacturing, nonclinical research, project management, protocol, safety, site selection, SOP, stability, toxicology
Comments Off
