The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.

Yesterday, Health Canada’s tobacco inspectors conducted simultaneous seizures of little cigars at three Quebec-based importers. / Hier, des inspecteurs du tabac de Santé Canada ont procédé à des saisies simultanées de petits cigares chez trois importateurs du Québec.

17 weight loss products; Uprizing 2.0; Get Stiff, Maxi Mize; Ying Da Wang tablets; Slimina weightloss capsules, S-shape slim capsules; Athri-Eze, Sear Heang Tienchi Tu Chung Wan, Wiku Jahe Kencur (Akur Mujarab), Cap Wijaya Kusuma (An Ki It); Cardiotium, Paidusu, SlimEasy Herbs Capsule, Tianran Zuanshi Xianweisu; [LuShenPai] Specific Hou Ton Qing, [AA] Pe Min Kan Wan / 17 weight loss products; Uprizing 2.0; Get Stiff, Maxi Mize; Ying Da Wang tablets; Slimina weightloss capsules, S-shape slim capsules; Athri-Eze, Sear Heang Tienchi Tu Chung Wan, Wiku Jahe Kencur (Akur Mujarab), Cap Wijaya Kusuma (An Ki It); Cardiotium, Paidusu, SlimEasy Herbs Capsule, Tianran Zuanshi Xianweisu; [LuShenPai] Specific Hou Ton Qing, [AA] Pe Min Kan Wan

Ms. Eve Adams, Member of Parliament for Mississauga-Brampton South, on behalf of the Honourable Leona Aglukkaq, Federal Minister of Health, today announced support to the Canadian Home Care Association for the development of a policy planning and evaluation tool, called the Home Care Policy Lens.

Further to previous communications, Health Canada is advising Canadians that we have identified two additional Male and Female Harmony retail stores that were selling unauthorized health products.