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: draft
New Disclosure Requirements for FDA Advisory Committees
Seldom, very seldom, does complete truth belong to any human disclosure. – Jane Austen On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees. If implemented, the draft guidance would increase transparency into … Continue reading
Posted in FDA, Industry News
Tagged advisory committees, draft, FDA, guidance, Margaret Hamburg, transparency, waivers
1 Comment
