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Generic manufacturers say counterfeiters are unlikely to target their drugs because they are inexpensive and generate thin profit margins, and as a result, the products may not require the expensive anticounterfeiting technology recommended last week by the FDA.
The White House’s official revelation of one of the worst kept secrets in Washington — that FDA Commissioner Mark McClellan is President Bush’s selection to take over at the Centers for Medicare & Medicaid Services (CMS) — has triggered a shuffling of leadership roles at the FDA.
The FDA has ignored pleas from PhRMA to implement paper pedigree requirements in the Prescription Drug Marketing Act of 1987 (PDMA) immediately, announcing it will continue to stay the requirements for another 32 months while it oversees industry’s adoption of electronic pedigrees using track-and-trace technologies.
PerkinElmer Life Sciences has reached an agreement with the FDA that will allow it to resume producing and shipping various neonatal chemistry systems and immunoisoelectric focusing diagnostic kits.
Inamed's silicone breast implants received Class III CE Mark approval and recertification in the European Union (E.U.) last week, a decision that is at odds with a recently upheld 11-year ban on the implants in the U.S.
President Bush has selected FDA Commissioner Mark McClellan to be the next administrator of HHS' Centers for Medicare & Medicaid Services (CMS), the White House announced Feb. 20.
Cordis has completed patient enrollment in a randomized study to pit its Cypher sirolimus-eluting stent against Boston Scientific's Taxus Express2 paclitaxel-eluting stent.
A French firm's failure to translate its 483 response letter and supporting documents into English prior to submitting them to the FDA may have lead to an avoidable warning letter.
The FDA has revised the voluntary (FDA 3500) and mandatory (FDA 3500A) MedWatch reporting forms to increase scrutiny of adverse events involving reprocessed single-use devices (SUDs).