Antibiotics - The Perfect Storm

We need new antibiotics to fight infections caused by resistant bacteria. But the marketplace, the structure of the pharmaceutical industry, regulatory agencies, and difficult science are conspiring to deny us the products we need. This blog will present perspectives and developments in the fight for new antibiotics.

Thursday, March 31, 2011

FDA HAP/VAP Discussion March 30

Image via Wikipedia As I noted in my last blog, I did have a conversation with the FDA on March 30 regarding their draft guidance on trial ...

Sunday, March 27, 2011

Pfizer Update etc.

Image by Getty Images via @daylife OK. I’m back and swamped. But during my absence, several pieces of information have filtered in regar...

Monday, March 14, 2011

Absence

I'm sorry to disappoint all of you out in antibiotic land - but I'll be on vacation (the "V" word as Bob Levy used to say ...

Thursday, March 10, 2011

When it comes to antibiotics, the Pharmaceutical Industry is a wimp!

I guess it will not surprise anyone to hear that, when it comes to directly challenging the FDA, pharmaceutical companies, large and smal...

Thursday, March 3, 2011

Antibiotics and FDA - Industry must take the lead.

Image via Wikipedia After my conversation with Brad Spellberg as noted in the previous blog , I have come to the conclusion that the ways f...

Sunday, February 27, 2011

Brad Spellberg Speaks. Antibiotics and the FDA - Present and Future

(Brad and I have been corresponding. He gave me permission to post this email in hopes of engendering a transparent, public discussion ...

Friday, February 25, 2011

Antibiotics - FDA 1, Americans 0

I know that you will all be surprised to hear that I have not had a response from Kathleen Sibelius, nor from the FDA for that matter. ...

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