FDA New Drug Safety Initiative
New Drug Safety Initiative. The Food & Drug Administration (FDA) is going to be giving drugs more scrutiny once they are approved and on the market. The new policy comes as lawmakers, concerned by the rash of recent drug recalls, have been urging the FDA to step in and implement standards to help alleviate these issues. Also, … [Read more...]
Ketek case keeps glare on reform
The FDA Missteps in Approving the Ketek Antibiotic. The Food and Drug Administration's missteps in approving the controversial antibiotic Ketek were cited at a congressional hearing yesterday as further evidence of the need for major drug safety reform. FDA whistle-blowers, medical experts and members of Congress said the FDA in … [Read more...]
FDA Maverick Whips Merck, Pfizer
FDA Maverick Graham Highlighted New Risks. The makers of some blockbuster painkillers could be nursing some wounds of their own. David Graham, a maverick drug safety expert at the Food and Drug Administration, has once again taken swings at so-called Cox-2 inhibitors. In testimony during a special hearing on Thursday, Graham … [Read more...]
How to Improve Drug Safety
Drug Safety In The United States. It has been a tough three years for the Food and Drug Administration, which until recently was credited with providing the United States with the safest drug supply in the world. In September, Merck withdrew Vioxx from the market after a study showed that the drug significantly increases the … [Read more...]
Attempt to Discredit Whistle-Blower Alleged
FDA Calls A Group That Protects Whistle-Blower. Managers at the Food and Drug Administration last month anonymously called a group that protects whistle-blowers in an attempt to discredit an outspoken agency safety officer who was challenging the FDA's drug safety policies, the legal director of the whistle-blower group said … [Read more...]
