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CDER plans to increase cooperation with European counterparts and make more use of databases as sources of safety data as it hones its approach to drug safety monitoring. Read More
Brand and generic drugmakers want the FDA to take responsibility for safety labeling changes to all drugs with at least one generic equivalent and scrap its proposed rule to give generics firms the ability to update label safety information independently. Read More
A federal judge upheld the FDA’s decision to strip Ranbaxy of its tentative ANDA approvals for two drugs because of GMP problems at manufacturing facilities, but nonetheless blasted the agency, saying it never should have issued the approvals in the first place. Read More
The FDA is warning that Pfizer’s Chantix smoking-cessation aid may cause seizures or, when taken with alcohol, lead to unusual or aggressive behavior. Read More
Sun Pharmaceuticals is recalling 5,322 bottles of Ketorolac tromethamine ophthalmic solution in the U.S. and Puerto Rico for failing to meet specifications. Read More
Particulate contamination and a labeling error prompted Hospira to recall single lots of two injectable drugs, 0.9 percent sodium chloride injection and magnesium sulfate injection in 5 percent dextrose. Read More
Brand and generic drugmakers want the FDA to take responsibility for safety labeling changes to all drugs with at least one generic equivalent and scrap its proposed rule to give generics firms the ability to update label safety information independently. Read More
The FDA Tuesday ordered drugmakers in the $1.6 billion testosterone-replacement therapy market to update their labels with warnings of the potential for increased heart attack risks when used for aging-related low testosterone. Read More