M e t h o d s Data sources: U.S. Food and Drug Administration (FDA) Web site; clinical trial registry of the drug manufacturer; and 2 large, recently published trials (Diabetes REduction Assessment with ramipril and rosiglitazone Medication [DREAM] trial and A Diabetes Outcome Prevention Trial [ADOPT]). Study selection and assessment: Randomized controlled trials (RCTs) that compared RGZ with p...

A chain of custody (COC) is required in many laboratories that handle forensics, drugs of abuse, environmental, clinical, and DNA testing, as well as other laboratories that want to assure reliability of reported results. Maintaining a dependable COC can be laborious, but with the recent establishment of the criteria for electronic records and signatures by US regulatory agencies, laboratory in...

Fibromyalgia syndrome (FMS) is a common chronic musculoskeletal pain disorder of unknown etiology and characterized by generalized body pain, hyperalgesia, and other functional and emotional comorbidities. Despite extensive research, no treatment modality is effective for all FMS patients. In this paper, we briefly review the history of FMS and diagnostic criteria, and potential pathophysiologi...

In 2010 the US Food and Drug Administration (FDA) stated that it would issue guidance on its oversight of laboratory-developed tests (LDTs), and in July of that year the FDA held a public meeting to receive feedback on a risk-based application of LDT oversight (http:// www.fda.gov/MedicalDevices/NewsEvents/Workshops Conferences/ucm212830.htm). The FDA acknowledged that LDTs have been in existen...

Abstract Background/Introduction Empagliflozin was approved by the US Food and Drug Administration (FDA) European Medicines Agency (EMA) for reducing cardiovascular mortality heart failure (HF) hospitalization in both patients with HF reduced ejection fraction (HFrEF) preserved (HFpEF). Purpose Limited data are available on generalizability of empagliflozin to clinical practice. Therefore, we e...

Bioinformatics is the design and development of computer-based technology to support the life sciences (1). At FDA, bioinformatics means the design, development, and use of modern computer systems to efficiently and effectively manage the regulatory product information supply chain, along which medical product information travels among the many relevant organizations (eg, study data travel from...

Sparsity-inducing multiple kernel Fisher discriminant analysis (MK-FDA) has been studied in the literature. Building on recent advances in non-sparse multiple kernel learning (MKL), we propose a non-sparse version of MK-FDA, which imposes a general lp norm regularisation on the kernel weights. We formulate the associated optimisation problem as a semi-infinite program (SIP), and adapt an iterat...

Professor Lars Noah deserves much credit for exposing some of the myriad ways in which the Food and Drug Administration (FDA) has consistently sought to expand its authority through questionable, and perhaps in some cases abusive, legal practices.1 As Professor Noah observes, there are signs that the federal courts’ century-long honeymoon with the FDA may be ending2—and perhaps the FDA never de...

BACKGROUND Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved ("off-label") uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic d...

Alzheimer’s disease is the most common cause of dementia, accounting for 60-80% of all cases in the United States. It is clinically diagnosed based on the presence of cognitive impairment that severely interferes with the activities of daily living. A pathological diagnosis is only possible after verification of the presence of amyloid β plaques in brain tissue. Misdiagnosis may lead to unneces...