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: in vitro diagnostics
FDA Guidances – December 2010
Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in December 2010, including a few from the first week of January 2011 … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged adverse events, FDA, guidance, in vitro diagnostics, labeling, postmarketing
Comments Off
FDA Guidances – November 2010
Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in November 2010 (links go directly to PDF documents).
Posted in FDA, Regulatory Strategy
Tagged Cato Research, cell therapy, clinical trials, eCTD, FDA, guidance, in vitro diagnostics, medical devices
Comments Off
September 2010 FDA Guidances
Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in September 2010 (links go directly to PDF documents). Special … Continue reading
Posted in FDA, Industry News
Tagged clinical trials, FDA, guidance, in vitro diagnostics, IND, labeling, PDUFA, safety
Comments Off
June 2010 FDA Guidances
Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in June 2010 (links go directly to PDF documents). Special … Continue reading
Posted in FDA
Tagged bioequivalence, FDA, guest post, guidance, in vitro diagnostics, medical devices
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
