The impact of a computer-based infectious diseases electronic antibiotic advice and approval system ("IDEA(3)S") was assessed as an alternative to a labour-intensive, phone-based approval system. IDEA(3)S-based approvals replaced 48% of all approvals for the most frequently requested antimicrobial agents (ceftriaxone/cefotaxime, vancomycin) and were associated with stable overall rates of antim...

New medical devices are subject to a regulatory scheme designed to ensure safety and effectiveness that is administered by the United States Food and Drug Administration (FDA). Gaining approval to market a device for a specific clinical indication may be time-consuming and costly, particularly for one that poses a potentially unreasonable risk of patient injury and represents genuinely new medi...

When Policy Topic is covered A number of indications for chelation therapy have received Food and Drug Administration (FDA) approval and for which chelation therapy is considered standard of care treatment. They include:  extreme conditions of metal toxicity;  treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) and due to non-transfusion-dependent thalas...

lamellar keratoplasty (lk) has been a well established technique of corneal transplantation. recent improvements in surgical instruments have revolutionized the procedure introducing a new technique employing deeper corneal dissection. this review article describes the indications, techniques, outcomes and complications of deep anterior lk.

The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this article, we review regulatory issues related to the ...

This case highlights clinical dilemmas faced by physicians when treating patients with conditions for which there are limited or no FDA-approved treatment options. First, it raises questions about when it is appropriate to prescribe medications for "off-label" indications and what might be the ethical and legal implications of doing so. It also prompts us to consider why pharmaceutical companie...

The field of therapeutic focused ultrasound, which first emerged in the 1940s, has seen significant growth, particularly over the past decade. The eventual widespread clinical adoption of this non-invasive therapeutic modality require continued progress, in a multitude of activities including technical, pre-clinical, and clinical research, regulatory approval and reimbursement, manufacturer gro...

Imaging biomarkers are accepted surrogate endpoints for several therapeutic indications in clinical research and are increasingly forming the basis for regulatory approval. The appropriate clinical trial design and imaging acquisition protocol ensures the accuracy, quality and consistency of imaging data submitted to regulatory agencies. Two of the most widely used medical imaging technologies ...

Drug repositioning (DR) is the process of identifying new indications for existing drugs. DR usually focuses on drugs that have cleared phase-I safety trials but has yet to show efficacy for the intended indication. Therefore, DR can probably skip the preclinical and phase-I study, which can reduce the cost throughout drug development. However, the expensive phase-II/III trials are required to ...

Hematopoietic stem cell transplantation (HSCT) has been practiced for more than 30 years. Hematological malignanciesare the main indications for this treatment. However, its indications in adults are different from children.Advances in chemotherapy and target therapy have improved treatment outcome of some of the very high riskcancers, and changed indications of HSCT in children. Multi-center c...