The FDA is advising Newport Medical Instruments to include corrective actions instituted to resolve continuing complaints regarding the battery life for its HT-50 Homecare ventilators in the firm’s response to a recent warning letter.
Abbott Laboratories is retaining an outside consultant to audit the manufacturing and quality systems (QSs) at its diagnostics division following a request in a March 13 FDA warning letter, Abbott told D&DL.
The FDA added noncompliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM).
The number of children receiving prescriptions for antidepressants dropped following warnings from the FDA about the increased risk of suicidal behavior associated with the drugs, according to a new study.
Two leading House members sent a letter to FDA Commissioner Andrew von Eschenbach asking him when he would have to alert agency employees about possible layoffs if the Prescription Drug User Fee Act (PDUFA) is not reauthorized.
Two leading House lawmakers are investigating FDA Commissioner Andrew von Eschenbach’s recent testimony on Ketek over concerns that he may have “intentionally misled” a subcommittee about the drug’s approval process.