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October 28, 2013
Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.
October 22, 2013
FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.
October 16, 2013
Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.
Vaporous hydrogen peroxide, nitrogen dioxide, chlorine dioxide, and carbon dioxide technologies can be used in pharmaceutical manufacturing to sterilize or disinfect.
October 07, 2013
During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.
September 30, 2013
FDA publishes guidance on ANDA submissions.
September 18, 2013
Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.
September 12, 2013
FDA updates guidance to reflect advances in technology.
September 09, 2013
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
September 07, 2013
Video recorded at Validation Week Canada