Author Archive
More Regarding Merit of Peer review
Last week the New York Times had a major article devoted to web alternatives to peer review. Actually does not describe an alternative to peer review but rather an alternative way of doing peer review via the web. The concept is not new, but by getting major coverage by the NYT, then perhaps web-mediated review [...]
Regulatory Medical Writing Conference
I am a speaker at what I believe will be a very interesting regulatory medical writing conference on September 22-23. The conference is organized by ExL Pharma. Here’s a link to the conference program. Focus of the program is really spot on:
Uncover innovative strategies to streamline the document review process
Learn how the medical writing department is being consolidated and reorganized [...]
FDA and Lifestyle Drugs — The Next Chapter in the Story
For those who may have missed the news from last week, Vivus Pharmaceuticals missed big time with Qnexa. Their FDA Endocrinologic and Metabolic Drugs advisory committee voted against recommending the anti-obesity drug for approval, basing their decision primarily on the absence of long-term safety data. The committee vote was 10 to 6 against approval. A comment made [...]