RSS Feed
Search Ask-Cato.com
Tags
adverse events biologics 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 labeling manufacturing marketing application medical devices NDA NIH nonclinical research oncology Phase 1 Phase 2 postmarketing protocol regulatory affairs safety statistical analysis toxicology transparency venture capital warning letters webinarCategories
- Clinical Trials (52)
- Conferences and Meetings (34)
- eCTD (26)
- FDA (71)
- 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)
Monthly Archives: September 2010
Future of Clinical Trials – Conference Review
On September 15-17, I attended the Future of Clinical Trials conference produced by Leo Intelligence. The conference consisted of professionals from many aspects of clinical drug development. The first two talks set the stage for the rest of the conference and … Continue reading
Annual Reports: A Time for Reflection
You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year? Quite possibly. In the rush to keep things moving, it’s all too easy to not take the time … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged 21 CFR, adverse events, annual report, clinical trials, CMC, drug development, eCTD, FDA, IND, nonclinical research, protocol
Comments Off
Download the Regulatory Compliance Webinar Slides
Earlier today, Cato Research hosted a webinar titled, “Regulatory Affairs and Compliance: Common Sources of Deficiencies Identified by the Regulatory Authorities in the United States and Canada.” For those of you who are interested, the slides from Dr. Sheppard‘s presentation … Continue reading
Posted in FDA, Health Canada, Regulatory Strategy, Webinars
Tagged FDA, Health Canada, webinar
1 Comment
35th European Society for Medical Oncology Congress
Image via Wikipedia The annual European Society for Medical Oncology (ESMO) meeting brings together medical oncologists from both Europe and all parts of the world. As per ESMO’s 2010 meeting President, Dr. David Kerr, announcement: The ESMO Congress is a … Continue reading
Biomarker Qualification and Validation: Where are We Now?
Personalized medicine. The pinnacle of healthcare where treatment for a patient’s disease is specifically tailored for his or her genetics and disease characteristics. As the era of blockbuster drugs is drawing to a close, the era of personalized medicines is … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biosimilar, clinical trials, drug development, FDA, guidance, personalized medicine
2 Comments
