Fda Warns: Swine Flu Scams Lurk On The Internet
These and other products making bogus claims to prevent or treat swine flu are flooding the Internet as scam artists prey on the publics fears while the vaccine is delayed and real Tamiflu – made by Switzerlands Roche Group – is rationed.
Every problem, it would seem, is a sales opportunity. Some of the products appear [...]
Complaints By Unhappy Lasik Patients Spurred Fda Warning, Study
The Food and Drug Administration said yesterday that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery. The agency also said it began a long-planned study with the National Eye Institute and the Department of Defense to examine how the laser procedures affect patients quality of life. [...]
Complaints By Unhappy Lasik Patients Spurred Fda Warning, Study
The Food and Drug Administration said yesterday that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery. The agency also said it began a long-planned study with the National Eye Institute and the Department of Defense to examine how the laser procedures affect patients quality of life. [...]
Fda to Study Negative Effects Of Lasik Eye Surgery
The FDA says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience negative side effects following surgery.
The first phase of the project is already under way, with plans for an online questionnaire to help patients gauge their quality of life following surgery, according [...]
Device Approval Exposes Political Pressure On Fda
In a sweeping critique Thursday, FDA leadership said the agency failed to protect its scientists from outside pressure after they twice rejected ReGen Biologics Menaflex device.
The Hackensack, N.J.-based company ultimately won approval last December after enlisting the support of four New Jersey lawmakers, who urged then-FDA Commissioner Andrew von Eschenbach to intervene on the companys [...]
Wyeth Sues Fda to Block Competitor Generic Antibiotic
Madison, N.J.-based Wyeth filed the lawsuit in U.S. District Court in Washington, D.C., seeking a temporary restraining order and a preliminary or permanent injunction.
The lawsuit seeks to prevent Orchid Chemicals & Pharmaceuticals Ltd. of Chennai, India, from selling a generic version of Zosyn that the FDA approved last week. The suit also asks the court [...]
Fda Medical Device Approvals Get External Critique
The nonprofit Institute of Medicine will conduct a two-year review of FDAs so-called 510k review procedure, which allows device companies to quickly launch products similar to those already on the market.
The announcement Wednesday garnered approval from lawmakers on Capitol Hill who have been skeptical of the FDA program.
“I have long been concerned that the 510k [...]
Fda Ban On Flavored Cigs Takes Effect
The ban on manufacturing, importing, marketing and distribution includes candy-, fruit- and clove-flavored cigarettes, which health and federal authorities say are more appealing to youth. It does not include a ban on menthol or other flavored tobacco products like cigars – issues that the FDA is studying.
“Candy- and fruit-flavored cigarettes are a gateway for many [...]
Fda Requires Bullish Amputation Alarm On Sedative
The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.
Wyeth had appealed the case up to the [...]
Fda Cracks Down On Ibuprofen Pain Relief Gels
Regulators said in a statement Thursday the companies do not have federal permission to market their products, which mix the popular pain relief drug with other ingredients. While ibuprofen is available in a variety of tablets like Advil, the FDA has not approved any ointments containing the drug.
“These companies have an obligation to demonstrate to [...]