Regulatory and Drug Approvals News
FDA Takes Action Against Maryland Veal Calf Dealer
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues. The complaint, filed Nov. 13, 2009, in the U.S.
FDA Issues 22 Warning Letters To Web Site Operators
The U.S. Food and Drug Administration completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.
Pew Health Group Statement On Senate Mark Up Of The FDA Food Safety Modernization Act (S. 510)
Sandra Eskin, director of the Pew Health Group's Food Safety Campaign, has issued the following statement regarding the markup of the FDA Food Safety Modernization Act by the Senate Health, Education, Labor, & Pensions Committee: "The Pew Health Group applauds the members of the Senate Health, Education, Labor, & Pensions (HELP) Committee for approving the FDA Food Safety Modernization Act (S.
Otsuka Pharmaceutical Europe Ltd Withdraws Its Application For An Extension Of Indication For Abilify (aripiprazole), Europe
The European Medicines Agency has been formally notified by Otsuka Pharmaceutical Europe Ltd of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Abilify (aripiprazole) tablets, orodispersible tablets and oral solution.
Spineology Receives FDA Clearance For Capture™ Facet Screw System
Spineology Inc., developer and manufacturer of minimally invasive spinal surgery devices, announced today that it has received FDA clearance for its minimally invasive surgery (MIS) Capture™ Facet Screw System. The Capture System was developed by Spineology in mid-2009 under the direction of Dr. Chet Sutterlin, product development consultant.
Arizona Medtech Company's Technology Breakthrough The First To Achieve FDA Approval For See/Treat Ultrasound
Guided Therapy Systems, LLC (GTS), a leading medical technology company, is the first company in the world to develop and commercialize products that employ a unique form of ultrasound technology, Intense Therapeutic Ultrasound (ITU).
Genentech And Biogen Idec Receive A Complete Response From The FDA For Rituxan For Chronic Lymphocytic Leukemia
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S.
FDA Advisory Committee Finds Data Support The Safety And Effectiveness Of Prevnar 13™ Vaccine For The Prevention Of Invasive Pneumococcal Diseas
Pfizer Inc (NYSE:PFE) announced today that the U.S.
FDA Announces New Warning On Plavix: Avoid Use With Prilosec/Prilosec OTC
Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17. New data suggest that when patients take both Prilosec and Plavix, Plavix's ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.
FDA Takes Action Against Dairy Farm And Owner
On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md.
