December 7, 2011
Plan B oral contraceptive (levonorgestrel 1.5mg), commonly known as the “morning after” pill, has been available for women over 17 for several years without a prescription. The eventual granting of non-prescription status followed a long and somewhat tortured regulatory pathway … Continue reading →
September 16, 2009
Yesterday the Food and Drug Administration announced the approval of flu vaccines for the H1N1 flu virus, popularly known as Swine Flu, being manufactured by four separate firms. The amount of time between the initial outbreaks of H1N1 this Spring, … Continue reading →
December 29, 2008
Ferring Pharmaceuticals is having a good month and have gotten two significant Holiday gifts, as do patients with prostate cancer. Last week, the CHMP announced approval of Ferring Pharmaceutical's new treatment for prostate cancer, Degelarix. Today, the FDA followed suit … Continue reading →
I took last week off for the holidays. Expecting guests, planning menus and my other regular duties left no time for posting and I suspected, little time for others to be reading. However, in spite of the holidays, things did … Continue reading →
December 16, 2008
Here I am – speaking of Complete Response Letters. What follows is a short tutorial on the communications aspects of CRLs. NOTE ADDED OCTOBER 19, 2010 – There has lately been a great deal of interest in this … Continue reading →