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)
Tag Archives: labeling
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
New Guidances from FDA – May 2011
Here’s a list of the guidances released by FDA in May 2011 (along with a couple that were released inthe first week of June), compiled by Cato Research Regulatory Scientist Cathy Anderson. Commercially Distributed In Vitro Diagnostic Products Labeled for … Continue reading
Posted in FDA
Tagged ANDA, clinical investigator, FDA, financial disclosure, guidance, in vitro diagnostics, labeling, medical devices, submissions
Comments Off
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
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
