Blogs about: Drug Approvals And Regulation
Featured Blog
Patent exclusivity and biosimilars: what's a reasonable compromise?
The biotech industry, through the Biotechnology Industry Organization (BIO), has been arguing in favor of a 12-year exclusivity period for new biological agents from the initial date of approval. Sena… more →
HEALTH + VISION
Patent exclusivity and biosimilars: what's a reasonable compromise?
Sitemaster wrote 5 months ago: The biotech industry, through the Biotechnology Industry Organization (BIO), has been arguing in fav … more →
A sad case all around ...
— 1 comment
Sitemaster wrote 1 year ago: I need to state a theoretical conflict of interests up front. I am a member of the Board of Director … more →
I'd have more to say but I can't stop laughing
Sitemaster wrote 1 year ago: So you’ll be glad to know it’s not just the health care and the pharmaceutical industrie … more →
Sharing in a glass half full
Sitemaster wrote 1 year ago: An insightful article by Robert Goldberg of the Centers for Medicine in the Public Interest, entitle … more →
NICE ... or not so nice? The economics of perception.
Sitemaster wrote 1 year ago: Yesterday the UK’s National Institute for Health and Clinical Excellence (NICE) concluded that … more →
Talking to national payers
Sitemaster wrote 1 year ago: Now this looks like a bright idea! Let’s actually talk to the ultimate payers and give them so … more →
Reagan-Udall: an update
Sitemaster wrote 1 year ago: According to former FDA Commissioner Mark McClellan (now the chairman of the Reagan-Udall Foundation … more →
Lordy ... I have competition out there!
Sitemaster wrote 1 year ago: I gather Andy von Eschenbach is now a blogger too! He’s going for once a week and you can … more →
Vytorin, Zetia, and expectation management
Sitemaster wrote 1 year ago: What we seem to be seeing in reactions to the Vytorin clinical trial “scandal” is a case … more →
New access to experimental agents for terminal cancer patients in the UK
Sitemaster wrote 1 year ago: According to a report published in the Daily Telegraph, the Department of Health in the UK has given … more →
Hooray for Janet Woodcock ...
Sitemaster wrote 1 year ago: Interviewed for an article in today’s issue of the Financial Times, the newly reinstated head … more →
Let's stop bashing the FDA!
— 2 comments
Sitemaster wrote 1 year ago: FDA bashing is a sport with a long history. Some players have been at it for years. Others are newer … more →
Approval of safe drugs without effectiveness data: is it a real option?
Sitemaster wrote 1 year ago: The biotech investor community and many others have demonstrated profound difficulty in recent years … more →
