Regulatory and Drug Approvals News
Regulatory Affairs and Drug Approvals News
Onset Medical Receives U.S. FDA Marketing Clearance For The SoloPath™ TransFemoral Endovascular Access Catheter
Onset Medical Corporation announced today the Company has received U.S. FDA 510(k) marketing clearance for the Company's SoloPath™ TransFemoral Endovascular Access Catheter. Onset's SoloPath Endovascular Access Catheters are designed to provide access to diseased arteries at a relatively small catheter size and then be expanded to provide a conduit for the delivery of larger diameter devices.
FDA Issues 2009 FDA Food Code
The Food and Drug Administration announced the publication of the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry.
FDA Approves Drug Treatment For Rare Cancer
The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL). Cutaneous T-cell lymphoma is a slow-growing cancer of infection-fighting white blood cells called T-lymphocytes. Most cases start with dry skin, red rash, and itching that can become severe.
FDA-Approved Drugs Eliminate, Prevent Cervical Cancer In Mice
Researchers at the University of Wisconsin-Madison School of Medicine and Public Health have eliminated cervical cancer in mice with two FDA-approved drugs currently used to treat breast cancer and osteoporosis. Published in this week's (Nov.
EpiCept Corporation Announces Health Canada Accepts Ceplene(R) Application For Review
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that Health Canada has accepted for review the Company's New Drug Submission (NDS) for Ceplene® (histamine dihydrochloride) for the remission maintenance of acute myeloid leukemia (AML) patients in first complete remission. Health Canada's performance target for the completion of review and a decision is within 300 days.
FDA Lags On 510(k) Medical Device Approvals
According to MassDevice.com, the online business journal of the medical device industry, medical device approval times under the Food & Drug Administration's 510(k) clearance process jumped 30 percent between 2005 and 2008. MassDevice's exclusive investigation of 10 years of FDA data,
Experts To Discuss DNA Barcodes And Their Uses
World experts are gathering this week to discuss DNA barcodes and their uses, covering a wide range of areas from medicine to agriculture, health to fraud, from smuggling to exploring our planet's prehistoric life. About 350 experts from 50 countries are meeting for the third International Barcode of Life conference that is taking place from 9 to 11 November in Mexico City.
FDA Warns Companies Against Marketing Illegal Flavored Cigarettes
The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites.
Novartis Receives Regulatory Approval In Germany For Celtura®, A Cell Culture-based Influenza A(H1N1) Pandemic Vaccine
Novartis announced that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A(H1N1) 2009 monovalent vaccine, Celtura®. Novartis continues to pursue registration in other major countries, including Japan and Switzerland.
Novartis Receives Regulatory Approval In Germany For Celtura®, A Cell Culture-based Influenza A(H1N1) Pandemic Vaccine
Novartis announced that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A(H1N1) 2009 monovalent vaccine, Celtura®. Novartis continues to pursue registration in other major countries, including Japan and Switzerland.
