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The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based. Read More
The FDA wants vaccinemakers to begin making adverse events reports electronically, and is launching a pilot study to assess whether its Adverse Event Reporting System is adequate for vaccine reports. Read More
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than is provided in a related House bill. Read More
Chicago-based Durata Therapeutics won FDA approval for Dalvance, an antibacterial for skin infections that is the first drug approved under the Qualified Infections Disease Product designation, the agency said Friday. Read More
Two California counties sued five drugmakers, alleging they improperly promoted addictive painkillers for chronic pain management, the latest localities to target opioid manufacturers as a way to combat abuse. Read More
A Las Vegas jury has found Takeda Pharmaceutical not liable for the bladder cancer of two women who took the Japanese drugmaker’s diabetes drug Actos, marking the firm’s fifth legal victory out of six cases that have gone to trial so far. Read More
Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said Thursday. Read More
Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More