RSS Feed
Search Ask-Cato.com
Tags
adverse events biologics biosimilar biotech cancer Cato BioVentures Cato Research CDER CDRH clinical investigator clinical research clinical trials CMC conference CROs DIA drug development eCTD efficacy FDA funding GlobalSubmit guidance Health Canada IND in vitro diagnostics labeling manufacturing marketing application medical devices NDA NIH nonclinical research oncology Phase 1 protocol regulatory affairs safety statistical analysis toxicology transparency vaccines venture capital warning letters webinarCategories
- Clinical Trials (52)
- Conferences and Meetings (34)
- eCTD (26)
- FDA (72)
- Guest Posts (5)
- Health Canada (6)
- Industry News (56)
- Project Management (1)
- Publications (7)
- Regulatory Strategy (36)
- Social Media (6)
- Statistics (9)
- Uncategorized (1)
- Venture Capital (10)
- Webinars (24)
Author Archives: Ask-Cato.com Contributor
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
Leave a comment
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
New FDA Guidances – September 2011
Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Reproductive and Developmental Toxicities – Integrating Study Results to Assess Concerns User Fee Waivers, Reductions, and Refunds for Drug … Continue reading
Posted in FDA, Regulatory Strategy
Tagged FDA, guidance, marketing, toxicology, validation
Comments Off
August 2011 FDA Guidances
Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading
