June 7, 2012 | Vol. 17 No. 12 | Full Issue in PDF Format
The FDA conducted 949 bioresearch monitoring inspections in fiscal 2011 — 220 fewer inspections than in the previous year — with the decrease spread among all relevant agency centers as they move to a more risk-based approach.
Eight major pharmaceutical companies are calling on drugmakers to publicize all clinical trial results — including unfavorable results — to address a “credibility gap” for industry-sponsored research.
FDA’s Center for Biologics Evaluation and Research (CBER) hopes to speed studies of biologic adverse events within the next five years by using the FDA’s Mini-Sentinel postmarket surveillance pilot in partnership with other government agencies and private organizations.
Sites should demand that clinical trial agreements and informed consent documents clearly state that the sponsor will cover the cost of treatment for an injury caused by an investigational drug or device upfront — not after a site doles out money or bills a patient’s insurance, site experts say.
The FDA’s discovery of an autoimmune mechanism that leads to serious drug-induced adverse reactions in some patients taking HIV drug Ziagen could give drugmakers new methods to more quickly identify a drug’s potential to cause severe reactions.
Vertex’s cystic fibrosis (CF) program took a hit May 29 when the company announced it had mischaracterized data from an interim analysis of an ongoing Phase II study of Kalydeco and investigational drug VX-809.
Drugmakers will see more explanation of the proper nonclinical steps to support safety of clinical trials and marketing applications for biotech drugs in an International Conference on Harmonisation (ICH) guidance addendum, just issued by the FDA.
Drugmakers could bring breast cancer treatments to market a decade earlier with new FDA guidance on trial designs for evaluating pathologic complete response (pCR) to support accelerated approval of drugs to treat high-risk, early-stage breast cancer.
Despite supporting a requirement that sponsors evaluate cardiac risks of weight-loss drugs both pre- and postmarket just months earlier, an FDA advisory panel voted 18–4 with one abstention in May in favor of approving Arena’s weight-loss drug lorcaserin, saying postmarket studies could suffice in this case.
Devices that continuously monitor a patient’s blood glucose level from his or her bedside can benefit patient care, but hospitals rarely use them. Now the FDA may be trying to change that.
Manufacturers hoping the FDA might minimize or remove trial requirements and adopt a more European-style approach to device approval got a strongly negative signal in a May agency report.
A good clinical practice (GCP) inspection can be an onerous task, so advanced preparation is critical to being ready for whatever requests the FDA throws at you, David Chesney told participations at a recent FDAnews webinar on organizing data and document archives in anticipation of inspections.
NDA and BLA supplements create more headaches for pharma companies than standard new drug or biologic applications, according to an analysis by the Tufts Center for the Study of Drug Development.
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