Monthly Archives: May 2006

FDA Credibility on the Line with RU-486

Today’s Washington Post carries news of the continued struggle over mifepristone and a renewal of effort on the part of RU-486 opponents to ban the compound because of eight deaths over the past several years.  Four of these have been … Continue reading

Posted in FDA Image, FDA Policy | 1 Comment

Pharma Regulatory Blog in Europe; Trends at Home

For those of you seeking an international perspective, I want to take the opportunity to introduce you to a blog developed by another lawyer, Richard Best called PharmaBlawg – Pharmaceutical Regulatory Issues on Common Law and European Countries.  According to … Continue reading

Posted in Useful Resources | Comments Off on Pharma Regulatory Blog in Europe; Trends at Home

Can the Administration Deliver on Bioshield?

On Friday, VaxGen shares feel 37% after it was reported that the company was going to file a legal claim against the government over its contract to produce an anthrax vaccine.  First awarded in November 2004, reports this past week … Continue reading

Posted in Current Affairs | Comments Off on Can the Administration Deliver on Bioshield?

Post-marketing Studies and Communications

Forgive me, but I am foregoing Weekly Roundup this week due to the very interesting development around post-marketing studies.  In any case, nothing too exciting happened, and we will include any developments in next week’s roundup. In the meantime, the … Continue reading

Posted in Pharma Industry Image, Proposed Legislation, Weekly Roundup | Comments Off on Post-marketing Studies and Communications

A CARE Act for the Mentally Ill

This is going to be a long posting, so either fasten your seat belt or click onwards. I worked for a long time as a lawyer on behalf of those with HIV.  When I first started, it was mainly comprised … Continue reading

Posted in Mental Health, Pharma Industry Image | 2 Comments