WASHINGTON — An advisory panel has urged the Food and Drug Administration to loosen its restrictions on the controversial diabetes drug Avandia, which was nearly wiped from the market in recent years after reports linking it to several heart-related complications.
WASHINGTON – After advancing two bills aimed at boosting the Food and Drug Administration’s regulatory authority over compounding drugs, Senate lawmakers released a report calling for a uniform statutory framework to better protect public health.
The Department of Justice has decided not to appeal a court decision striking down the Food and Drug Administration’s new graphic warnings on cigarette packages on First Amendment grounds.
In light of recent studies, the Food and Drug Administration cautioned that azithromycin, a drug used to treat bacterial infections, can cause abnormal and even fatal heart rhythms.
WASHINGTON – The Food and Drug Administration has proposed new rules for labeling medical products that are not made with latex.
Published: March 1, 2013
Tags: Children’s Motrin, consumer protection, drug litigation, failure to warn, FDA, Food and Drug Administration, Johnson & Johnson, Motrin, preemption, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
A Massachusetts jury awarded $63 million to a teenaged girl and her parents after the girl suffered an adverse reaction to Children’s Motrin that left her scarred and blind, with permanent brain and lung damage.
And the award may increase.
Published: February 7, 2013
Tags: ADHD, Daytrana, drug litigation, FDA, Food and Drug Administration, Institute for Safe Medication Practices, multidistrict litigation, Noven Therapeutics, product liability, Propecia, Proscar, QuarterWatch
Sexual side effects experienced by men taking the hair-loss drug Propecia may be permanent, according to a new report by a drug industry watchdog.
Published: February 4, 2013
Tags: Affordable Care Act, contraception, contraceptive mandate, Department of Health and Human Services, FDA, Food and Drug Administration, health care reform, HHS, Obamacare, Patient Protection and Affordable Care Act, Religious Freedom Restoration Act
The new federal requirement that all group health plans must include coverage for FDA-approved contraceptive methods probably violates the religious rights of an employer who is a devout Catholic, the 8th Circuit has ruled in granting a preliminary injunction.
There have been more than 80 deaths and thousands of injuries involving patients who underwent procedures with the da Vinci surgical robot, according to a new analysis of Food and Drug Administration adverse event reports.