RSS Feed
Tags
adaptive trials advertising advisory committees best practices biologics biosimilar biotech BLA cancer Cato BioVentures Cato Research CBER CDER CDRH clinical trials CMC conference DDMAC DIA drug development eCTD efficacy FDA GlobalSubmit guest post guidance IND inspections medical devices NDA NIH nonclinical research oncology outsourcing personalized medicine postmarketing protocol safety slides Social Media statistical analysis transparency venture capital warning letters webinarCategories
Archives
Links
Follow us on Twitter!
- Featured yesterday at Fierce Biotech IT - Cato lists five keys to success in adaptive trials http://bit.ly/aHry0A about 16 hours ago from TweetDeck
- RT @reuters: "Outgunned FDA tries to get tough with drug ads" http://bit.ly/btorHn 08:45:47 PM September 07, 2010 from web
- @MicroConstants Thanks for retweeting! 07:27:43 PM September 07, 2010 from TweetDeckin reply to MicroConstants
- New blog post: August 2010 FDA Guidances - http://ask-cato.com/mg 02:50:26 PM September 07, 2010 from WordTwit Plugin
Tag Archives: generic drugs
Generic Lovenox – Moving One Step Closer to Biosimilars
We bleed from similar veins. – Tupac Shakur Lovenox is not, I repeat, not a biologic therapeutic. It is derived from a biological source (pig intestines, yum), but it is not protein-based. However, the FDA’s approval of a generic form … Continue reading
Posted in FDA, Industry News
Tagged biologics, biosimilar, drug development, FDA, generic drugs
1 Comment
Drug/Biologic/Device Highlights from the Health Care Reform Bill
Cautious, careful people, always casting about to preserve their reputations… can never effect a reform. – Susan B. Anthony Last month, the company behind the FDA Law Blog, Hyman, Phelps & McNamara, P.C., prepared a memo that outlines the provisions … Continue reading
