We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority. Read More
British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following GMP guidelines. Read More
Companies throughout the drug supply chain that encounter suspected counterfeit products should file a report with the FDA and any affected trading partner within 24 hours, the agency says. Read More
Tramadol manufacturers have approximately 45 days to implement new labeling and security procedures now that the Drug Enforcement Administration has determined the opioid analgesic is a Schedule IV controlled substance. Read More
Drugmakers with products on the market in Europe have less than two months before they must start paying thousands of dollars in new fees to fund EU pharmacovigilance activities. Read More
Warning is unrelated to FDA’s investigation into risk of heart attack, stroke and death linked to blood clots in arteries in testosterone patients. Read More
Manufacturers of oral viscous lidocaine 2 percent solution must add a boxed warning to their product’s labeling that spells out the serious risks of using the painkiller to treat teething pain in children and infants. Read More
Top Republican lawmakers want the Obama administration to examine whether the FDA has the authority to impose a generic drug labeling rule, ratcheting up the rhetoric in an increasingly political battle over the controversial measure. Read More
After an exhaustive review, the FDA found no clear evidence of higher cardiovascular risks for diabetic patients taking olmesartan, and declined to set new restrictions on use of the widely-prescribed hypertension drug. Read More
The FDA said Friday it would require a warning label on all testosterone products detailing the general risks of developing blood clots in the veins. Read More
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel concluded last week, instead urging the agency to require postmarket observational studies. Read More
A Massachusetts insurer filed a lawsuit this week against Takeda and Eli Lilly in the U.S. District Court for the Western District of Louisiana for allegedly hiding cancer risks of its type 2 diabetes drug Actos. Read More