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The FDA’s final rule banning dietary supplements containing ephedra went into effect last week after last-minute legal maneuvering by a pair of manufacturers failed.
Pharmaceutical manufacturers reiterated their opposition to drug reimportation last week at the second public meeting of the HHS Task Force on Drug Importation, maintaining their contention that it is impossible to ensure that imported drugs are safe and effective.
Seeking to make Part 11 "less prescriptive," the FDA is calling on industry for advice as the agency considers whether to revise the rule or issue additional guidance documents.
The FDA has added three new single-use devices (SUDs) to the list of reprocessed SUDs requiring premarket clearance, a move that will force reprocessors of these devices to submit 510(k) clearance data by July 13, 2005, to continue marketing their products.
The FDA has issued a detention order for all transcutaneous electrical nerve stimulator (TENS) devices and acupuncture needles shipped by a Canadian repackaging firm cited for failure to maintain adequate quality systems (QS) and medical device reporting (MDR) procedures.
Several hundred complaints and adverse events lodged by European physicians in 2002 and 2003 against Johnson & Johnson subsidiary Cordis’ Cypher stent were never fully investigated, according to the FDA.
The FDA has determined that the active ingredient in a depression drug marketed before 1962 is effective, rather than “probably effective,” and the agency will use the brand product as a reference-listed drug to approve generic equivalents.