Weekly Roundup – 05/23/08

J0145922It is the Friday before Memorial Day weekend, and it was a long time in coming as far as I’m concerned.  I feel like the only person in Washington who came to work today.  It is a beautiful day and it promises to be a beautiful weekend.  I hope wherever you are, it is the same.  Meanwhile, here is a bit of what happened or was announced this week that I leave you with for the weekend. 

  • Senator Boxer Introduces New FDA Legislation on Devices – Senator Barbara Boxer (D-CA) introduced a bill week that is designed to bring greater accountability and transparency to the Food and Drug Administration’s (FDA) regulation of all medical devices, focusing primarily on post-marketing surveillance.  The bill (S.3020), the Food and Drug Administration Accountability and Transparency Act, will provide the FDA with several tools to help ensure the safety of these devices.  Interestingly, on another note, the HHS also announced "New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care."
  • Wyeth Receives Third Approvable Letter for Bazedoxifene – Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter on May 21 for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.  In the letter, the FDA requested information similar to that outlined in its approvable letter for bazedoxifene’s New Drug Application (NDA) for the prevention of postmenopausal osteoporosis issued in December 2007.  This included further analyses concerning the incidence of stroke and venous thrombotic events.  The Agency also identified specific questions concerning data collection and reporting and requested additional source documents.
  • Endocrinologic and Metabolic Drugs Advisory Committee to Meet – The Federal Register announced that the committee will discuss the role of cardiovascular assessment in the preapproval and post-approval settings for drugs and biologics developed for the treatment of type 2 diabetes mellitus.  The meeting will be held on July 1, 2008, from 8 a.m. to 6 p.m. and July 2, 2008, from 8 a.m. to 4:30 p.m.
  • Gasteroenterology and Urologic Medical Devices Panel to Meet – The Federal Register announced that the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Medical Enterprises, Ltd., for a drug/device combination product designed to prevent recurrence of bladder cancer.  The meeting will be held on June 25, 2008. 
  • Ophthalmic Devices Panel of the Medical Devices Advisory Committee to Meet – The Federal Register announced that this committee will meet on June 10, 2008 to discuss general issues concerning the post-market experience with various contact lens care products. The discussion will include recommendations on contact lens care product development topics such as preclinical testing and clinical performance measures, and labeling for contact lenses and lens care products.

      Have a good one everyone.  Note, no posting on Memorial Day! –

  • Note also that this posting was amended after the original 9:59 AM publication to include information on the Wyeth approvable letter and to correct a typo on the date for the Endo meeting. 

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