Simplifying Global Compliance
Articles Tagged with ''FDA''
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. Read More
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. Read More
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). Read More
Pharmacyclics will file a formal protest to require the FDA to review its new drug application (NDA) for its brain cancer treatment. Read More
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. Read More
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. Read More
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. Read More
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. Read More
A U.S. Food and Drug Administration (FDA) draft guidance released in March provides recommendations on reporting data from studies of diagnostic tests and identifies common “inappropriate practices.” Read More
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. Read More
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