Category Archives: Approval Announcements

HHS Secretary Directs FDA Decision on Plan B

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. ┬áThe eventual granting of non-prescription status followed a long and somewhat tortured regulatory pathway … Continue reading

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The Swine Flu Vaccine is Approved – If You Build it Will They Come?

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

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New Prostate Cancer Treatment Approved by FDA

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

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Playing Catch-up

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

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Speaking of Complete Response Letters

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

Posted in Approval Announcements, Complete Response Letters | 5 Comments