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: IND
Free Educational Webinar – Reasons to Switch to eCTD
UPDATE: The webinar slides are now available for download here (PDF). The eCTD format continues to grow as the standard for regulatory submissions worldwide, and the FDA has made it very clear that it prefers to receive submissions in eCTD … Continue reading
Posted in eCTD, Webinars
Tagged BLA, Cato Research, eCTD, FDA, GlobalSubmit, IND, NDA, webinar
Comments Off
Is FDA Issuing More Refuse-to-File Letters?
The June 2011 issue of Nature Reviews: Drug Discovery (volume 10, page 403) includes an interesting news brief regarding the apparent increase in Refuse-to-File (RTF) letters being issued by FDA in recent years. In a review of publicly available … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged Cato Research, clinical research, CMC, eCTD, FDA, IND, NDA, refusal to file
Comments Off
Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?
UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and … Continue reading
Posted in Clinical Trials, Webinars
Tagged adverse events, bioavailability, bioequivalence, clinical trials, FDA, guidance, IND, pharmacovigilance, safety, webinar
Comments Off
FDA Enforcement of New IND and BA/BE Safety Reporting Requirements
FDA announced at the end of March 2011 that the new IND and bioavailability/bioequivalence (BA/BE) study reporting requirements (final rule published September 29, 2010), originally effective on March 28, 2011, will not be enforced until September 28, 2011. FDA’s intent … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged 21 CFR, adverse drug reactions, adverse events, bioavailability, bioequivalence, clinical investigator, FDA, IND, safety
1 Comment
Therapeutics for Rare and Neglected Diseases – How Rare is Rare?
The U.S. National Institutes of Health (NIH) classifies a rare disease as affecting less than 200,000 individuals in the United States. As insignificant as this classification may sound, collectively there are more than 25 million people in the United States … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged analytical testing, biomarker, clinical trials, dos, exclusivity, FDA, IND, NIH, novel therapeutic, Orphan Drug Designations, tax credit, toxicology
Comments Off
