Protocols and planning key to avoiding warning letters; FDA
Better designed protocols and early identification of risks can improve trial quality and help avoid warning letters, said the FDA. In 2010, 95 per cent of US Food and Drug Administration (FDA) warning letters were related to the protocol. By designing a good protocol, identifying the goal of the trial, the risks involved, and sticking […]
Read More »Category : News
5 Indian Drug Companies Eager for US Entry After Clean Inspections
FDA has inspected the manufacturing plants of at least half-a-dozen Indian drugmakers, raising hopes that these companies will be able to export medicines to the world’s largest drug market, reports Khomba Singh from New Delhi. Several industry executives said teams of inspectors from the US Food and Drug Administration (FDA) did not find any major […]
Read More »Category : News
Smoked: Pfizer’s Chantix & Heart Problems
Yet another red flag is being raised about the Chantix smoking-cessation drug and the likelihood of cardiovascular problems. A new meta-analysis found that the Pfizer pill was associated with a 72 percent increased risk of serious adverse cardiovascular risks in smokers without a history of heart disease, and two authors suggest the FDA should consider […]
Read More »Category : News
FDA Clears Dendreon 2nd Facility
Dendreon Corporation recently received clearance from the U.S. Food and Drug Administration (FDA) to expand manufacturing facility for its cancer vaccine Provenge, in the U.S. The company’s Los Angeles facility can now be operational with 36 workstations. These facilities will be brought online in a staged manner. Earlier, in March 2011, Dendreon’s New Jersey facility […]
Read More »Category : News
Minnesota Pols Slam FDA For Device Approvals
In the ongoing war between device makers and the FDA, the Minnesota Congressional delegation has sent a terse letter to the agency over what they maintain is a slow-as-molasses approval process. This comes less than three months after a Congressional hearing in which FDA procedures were hotly debated and included testimony from patients who claimed […]
Read More »Category : News
FDA Issues A Serious Warning For An Abbott Drug
For the second time in less than two years, the FDA has issued a sobering warning about the Depakote epilepsy med sold by Abbott Laboratories. This time, the agency says that children born to mothers who take the anti-seizure drug or related products during pregnancy have an increased risk of lower cognitive test scores than […]
Read More »Category : News
For Ranbaxy, FDA Audit Is Much More Than Just an Inspection
Ranbaxy expects any day now a ruling from the FDA on whether its new finished dosage manufacturing plant in Mohali, Punjab, is up to GMP snuff. An inspection that began last week is nearing completion, says the Economic Times. Ranbaxy has a lot riding on the inspection. So does its Japanese parent, Daiichi. New Webinar […]
Read More »Category : News
Avastin & FDA Were Both On Trial: Dan Explains
After months of controversy, an FDA advisory panel yesterday voted unanimously to uphold an earlier agency decision to yank the breast cancer indication for Avastin, a widely used sold by Roche and its Genentech unit (see this). The run-up to the two-day meeting was highly contentious as the drugmaker accused the FDA panel of bias, […]
Read More »Category : News
Cephalon Warning Letter – June 28, 2011
SILVER SPRING, Md., Jun 28 2011—The FDA has posted on its website a letter sent to Cephalon regarding its website for Trisenox reviewing a number of problems. The letter is below. Franklin Vairinhos, Ph.D. Director, Regulatory Affairs Cephalon, Inc. 41 Moores Road Frazer, PA 19355 USA Dear Dr. Vairinhos: The Division of Drug Marketing, Advertising, […]
Read More »Category : News
R&D Spending In India Is Projected To Mushroom
Last year, the pharmaceutical industry spent about $2 billion on assorted R&D activities in India, but that figure is expected to reach a whopping $25 billion by 2025. The reasons are varied, but can be traced to expanding activities by Indian companies, additional government investment and a growing pool of qualified researchers, according to a […]
Read More »Category : News
