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Archive for the ‘REMS’ Category

FDA Asks Drug Maker to Monitor ESA Prescribing

Tuesday, February 16th, 2010

I have always heard that historically, FDA has pretty much just regulated the manufacture and marketing of the products it oversees (i.e., pharmaceuticals and medical devices, among others) but not the practice of medicine itself. Currently, though, FDA can mandate certain activities under a risk evaluation and mitigation strategy (REMS). ...

Can Tamper Evidence Reduce Risk?

Friday, December 11th, 2009

Recent cases of syringe tampering have made me wonder: Should prefilled syringes carry tamper evidence as part of a risk-mitigation strategy? Tamper-evident packaging is not required for prescription drugs. According to an FDA spokesperson, "the regulation that requires tamper-evident packaging (21 CFR 211.132) applies only to over-the-counter drugs, not prescription drugs." ...