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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.
Faced with soaring healthcare costs driven in part by biopharmaceutical therapies, federal policymakers should give the FDA power to approve follow-on biologics, AARP said.
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.
U.S. Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach has announced the creation of a new office that will address cultural issues within the agency.
A U.S. Food and Drug Administration (FDA) draft guidance released in March provides recommendations on reporting data from studies of diagnostic tests and identifies common “inappropriate practices.”
A clinical investigator failed to supervise a drug clinical trial she was conducting, delegating her responsibilities to a site management organization whose CEO committed multiple violations, according to an FDA warning letter.