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The FDA has cleared Mylan’s generic version of Upsher-Smith’s potassium drug Klor-Con, and the generics firm has already started shipping the product. Read More
Regulators in Australia are seeking input on proposed changes to drug labelling regulations that could save the public health system up to $30 million annually in hospital admission costs attributed to medication errors, but would cost industry millions of dollars to implement. Read More
Brazil's Anvisa issued a rule on June 18 establishing criteria for the priority review of small molecule drugs and biologics. Rule No. 37 applies to marketing authorization, postauthorization and clinical study applications. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn't manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. Read More
Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. Read More
European regulators warn that the lactation-control drug bromocriptine should only be used for compelling medical reasons, and should not be used routinely for preventing or stopping milk production after childbirth. Read More