Impax gets FDA warning letter for California plant
Impax Laboratories Inc said it received a warning letter from the U.S. health regulators after it inspected the specialty pharmacueticals company’s Hayward, California-based manufacturing facility. In its letter, the U.S. Food and Drug Administrator cited “deviations from current Good Manufacturing Practice for Finished Pharmaceuticals,” the company said. The deviations related to sampling and testing of […]
Read More »Category : News
BREAKING – Probe Deepens of Alleged Inside Trades at FDA
A federal inquiry into insider trading at the Food and Drug Administration, which has focused on an agency chemist who was charged in March, is expanding to look at other government employees, according to people familiar with the matter. Cheng Yi Liang, a longtime chemist at the FDA, and his son Andrew, who didn’t work […]
Read More »Category : News
CRO Employees Indicted For Falsifying Study Data
A doctor and a clinical research coordinator working for a contract research organization hired by the former Schering-Plough were indicted by the feds for falsifying study data. The clinical trial was designed to test a tablet the drugmaker was developing to treat allergies. June 21 – Webinar – Former FDA Chief Council Sheldon Bradshaw – […]
Read More »Category : News
Merial Fired Exec For Protecting Dogs
A former regulatory employee at the Merial animal health operation has filed a sensational lawsuit charging the Sanofi unit with deliberately covering up adverse event reports for its Heartgard Plus heartworm product for dogs and repeatedly rebuffing FDA admonitions to alter promotional material that overstated effectiveness. The trouble began in 2006, when Kari Blaho-Owens joined […]
Read More »Category : News
FDA signals it will regulate medical apps
As more medical mobile applications get developed, one thorny question has arisen: Is there anyone who should be verifying whether these apps are effective and safe? The question has come up, in particular, because of apps that claim to have a clinical component. They’re a small part of the app universe, but experts expect clinical […]
Read More »Category : News
South Carolina AG Sues Glaxo Over Avandia
And still another state attorney general has filed a lawsuit charging GlaxoSmithKline with fraudulently marketing its controversial Avandia diabetes pill. This time, South Carolina Attorney General Alan Wilson has gone to court, joining his counterparts in Louisiana and Utah . And the same issue is being raised – allegations that the drugmaker knowingly marketed a […]
Read More »Category : News
FDA Launches Web Portal on Enforcement Activities
The FDA announced May 26 the launch of a Web portal on the agency’s enforcement activities. The portal includes a searchable database of inspection information, including the names and addresses of inspected facilities, inspection dates, type of products involved and the final inspectional classification — no action indicated (NAI), voluntary action indicated (VAI) or official […]
Read More »Category : News
FDA Posts Inspection Findings, Common Violations
Facility inspection results, court actions and details of drugmaker practices that may jeopardize public health are now easier to find thanks to an FDA web portal dedicated to enforcement activities. The agency’s goal, part of Phase II of its Transparency Initiative, is to make its compliance-related activities “more accessible, downloadable and searchable.” June 21 – […]
Read More »Category : News
Abbott Cholesterol Pill Fails To Protect The Heart
A study run by the National Institutes of Health was ended 18 months early after finding that adding Niaspan to a statin in people with heart disease did not reduce the risk of cardiovascular events, including heart attacks and strokes. Moreover, Niaspan may have boosted the risk of ischemic events, raising questions about the benefit […]
Read More »Category : News
Parexel CEO: ‘We’re Undergoing Significant Change’
Yesterday, Pfizer reached an outsourcing deal with two large clinical research organizations – Parexel International and Icon. The move comes not long after the big drugmaker announced plans to close or shift various R&D operations and slash 3,500 jobs in order to save $1.5 billion. Such deals, of course, are not new as large drugmakers […]
Read More »Category : News
