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FDA officials sought to clear up questions about what standards the agency will apply when approving biosimilars, emphasizing that manufacturers must prove their products are “highly similar” to the reference product in order to win a green light. Read More
The FDA late Tuesday unveiled a broad plan that will change the way it inspects drugmakers, approves recalls, issues and reviews enforcement decisions, screens imports and tests products for quality, with drugmakers likely to start feeling the impact by the end of 2015. Read More
The FDA extended an indication for AbbVie’s Humira to treat childhood arthritis in younger patients, marking another win for the drugmaker seeking to get as much out of the blockbuster biologic before its patents start expiring in two years. Read More
Bristol-Myers Squibb has withdrawn its NDA for a hepatitis C combination drug of Daclinza and asunaprevir, citing concerns of an insufficient target population. Read More
European regulators are greatly expanding a public database for reporting suspected adverse drug reactions, adding roughly 1,700 more products to the site, the European Medicines Agency said. Read More
Australian regulators are urging tougher warnings on the cardiovascular risks of over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), as well as proposing new initiatives to better inform patients about CV risks associated with both the OTC and prescription-based painkillers. Read More
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
Limiting the concentration of OTC pediatric acetaminophen liquid drugs to 160mg/5mL would mitigate the risk of patients overdosing on the common products to reduce pain and fever, the FDA says. Read More
The FDA has issued a preliminary list of 20 disease targets under an initiative to spur drugmakers to include patient perspectives earlier in the drug development process. Read More
A large Texas compounder has rejected the FDA’s formal request to recall all of its sterile products after an inspection found 22 contaminated lots, a stance that means the dispute could move to court. Read More