Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA.

Objectives: US FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Medicines Agency (EMA), clinical data are reviewed independently by the Advisory Committee of Drug Registration (ACDR).

Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.

Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis. While each country has its own expedited review pathways to bring promising therapies to patients, there are some similarities and differences in pathways and timelines.

Drug shortages in Israel: regulatory perspectives, challenges and solutions.

Background: Pharmaceutical drug shortages (DSs) are a global problem which presents challenges to countries around the world. Shortages of pharmaceutical products may have a direct detrimental impact on public health and patients' wellbeing by causing delayed, or even lack of, treatment. Moreover, DSs may force both patients and caregivers to use unfamiliar drugs, which could lead to medication errors.

Orbital Rosai-Dorfman disease: a literature review.

Introduction: Rosai-Dorfman disease (RDD) is a rare histiocytic proliferative disorder with a predilection for the head and neck. Isolated orbital involvement without systemic clinical features is very uncommon.

Background: Classic histopathologic features include phagocytized but intact lymphocytes within large histiocytes; a conditioned termed emperipolesis.

Systemic absorption of mitomycin-C when used in refractive surgery.

Purpose: To determine whether corneal topical application of mitomycin-C (MMC) results in measurable plasma levels of systemic absorption.

Setting: Madigan Army Medical Center, Refractive Surgery Center, Fort Lewis, Washington, and Micro-Constants Laboratory, San Diego, California, USA.

Design: Case-control study.

Application of the AJCC 7th edition carcinoma of the eyelid staging system: a medical center pathology based, 15-year review.

Context: The purpose of this study was to conduct a quality improvement (QI), applied practical review of the American Joint Committee on Cancer (AJCC) 7th edition, Carcinoma of the Eyelid staging system. AJCC utilizes a primary tumor, lymph node, metastasis (pTNM) cancer staging approach.

Objective: We wanted to determine if the AJCC pTNM carcinoma staging system identified patients with highly aggressive carcinoma of the eyelid.

Ibuprofen transdermal ethosomal gel: characterization and efficiency in animal models.

A new ibuprofen transdermal nanosystem, designed by using an ethosomal carrier, was characterized and tested for its pharmacokinetic profile and therapeutic effects in animal models. It was found that the ethosomal nanosystem contains unilamellar vesicles with a normal size distribution of about 200 nm. The drug applied transdermally from the ethosomal gel was present in plasma for a longer period of time as compared to the oral administration and showed a high relative bioavailability.

Drug delivery applications with ethosomes.

Ethosomes are specially tailored vesicular carriers able to efficiently deliver various molecules with different physicochemical properties into deep skin layers and across the skin. This paper reviews the unique characteristics of the ethosomal carriers, focusing on work carried out with drug containing ethosomal systems in animal models and in clinical studies. The paper concludes with a discussion on the safety of the ethosomal system applications.

A new approach for skin tumor treatment: from delivery system characterization to in vivo evaluation.

Topical therapy for skin cancer is considered ineffective, due to insufficient penetration of the anticancer drug into the tumor located in the deep layers of the skin. The aim of this work was to investigate a new system, Tumorep DS, tailored to deliver the anti-cancer actives into the tumor cells in the deep skin and to induce cell differentiation. Tumorep DS containing 5-fluorouracil (5-FU) anticancer drug and a sulfoxide derivative, as a differentiation agent, was characterized and tested for storage stability.

Introduction of the 7th edition eyelid carcinoma classification system from the American Joint Committee on Cancer-International Union Against Cancer staging manual.

Context: The American Joint Committee on Cancer (AJCC) and the International Union Against Cancer commissioned the Ophthalmic Oncology Task Force to modify and update the ophthalmic chapters of the 7th edition of the AJCC Cancer Staging Manual.

Objective: To review the existing eyelid carcinoma chapter in the 6th edition of the AJCC Cancer Staging Manual for its clinical and research utility and to seek evidence-based revisions with the strongest medical foundation to use in updating the anatomically based TNM cancer staging system manual.

Data Sources: The 4-year Ophthalmic Oncology Task Force consisted of 45 tumor specialists from 10 countries and an extensive internal and external peer review process.

Severe eye injuries in the war in Iraq, 2003-2005.

Purpose: To document the incidence and treatment of patients with severe ocular and ocular adnexal injuries during Operation Iraqi Freedom.

Design: Retrospective hospital-based observational analysis of injuries.

Participants: All coalition forces, enemy prisoners of war, and civilians with severe ocular and ocular adnexal injuries.

Methicillin-resistant ascending facial and orbital cellulitis in an operation Iraqi Freedom troop population.

Purpose: To present a descriptive case series of methicillin-resistant ascending facial and orbital cellulitis in an Operation Iraqi Freedom troop population.

Methods: A physician's transfer records of patients cared for and or transferred from the 31st and 86th Combat Support Hospitals during Operation Iraqi Freedom between September 2004 and March 2005 were reviewed. Cases of facial and orbital cellulitis caused by a nasal mucosal source were included in the case series.

Testosterone ethosomes for enhanced transdermal delivery.

Physiological decrease in testosterone levels in men with age causes various changes with clinical significance. Recent testosterone replacement therapy is based mainly on transdermal nonpatch delivery systems. These products have the drawback of application on extremely large areas to achieve required hormone blood levels.

Use of self-expanding, hydrophilic osmotic expanders (hydrogel) in the reconstruction of congenital clinical anophthalmos.

Purpose Of Review: Rehabilitation of the congenitally anophthalmic orbit is frustrating to both the parents and physician. Traditional methods involve using progressively enlarging static acrylic conformers to expand the conjunctival socket, followed by placement of conventional static spherical orbital implants, dermis-fat grafts, or inflatable balloon expanders for orbital enlargement. Limitations of these methods typically result in less-than-optimal cosmetic outcomes, with retardation of bony orbital and overlying soft tissue growth adversely affecting midfacial growth and symmetry.

An evaluation of medical and chiropractic provider utilization and costs: treating injured workers in North Carolina.

Objective: To examine utilization, treatment costs, lost workdays, and compensation paid workers with musculoskeletal injuries treated by medical doctors (MDs) and doctors of chiropractic (DCs).

Design: Retrospective review of 96,627 claims between 1975 and 1994.

Results: Average cost of treatment, hospitalization, and compensation payments were higher for patients treated by MDs than for patients treated by DCs.

Cutaneous benign mixed tumor (chondroid syringoma) of the eyelid: clinical presentation and management.

Purpose: To describe the clinical presentation of cutaneous benign mixed tumor of the eyelid and its management options.

Methods: Periocular cases of cutaneous benign mixed tumor were gathered from members of an oculoplastics specialty Internet discussion group. A total of 9 patients are described in this retrospective, interventional case series.

Gaze-evoked amaurosis: a report of five cases.

Objective: To highlight the various causes of gaze-evoked amaurosis.

Design: Retrospective noncomparative interventional case series.

Participants: Five patients treated at our facility over the past 6 years.

Dominant familial congenital entropion with tarsal hypoplasia and atrichosis.

Background: Congenital entropion and atrichosis of the lower eyelids associated with tarsal hypoplasia is a rare condition, with isolated reports in the literature and without previous pathologic examination.

Methods: Case report. A father and son with mild entropion, lower eyelash atrichosis, and tarsal hypoplasia are described.

Chorioretinitis sclopetaria from BB ex memoria.

Chorioretinitis sclopetaria presents a characteristic pattern of choroidal and retinal changes caused by a high velocity projectile passing into the orbit, in close proximity to the globe. While it is unlikely that a patient should completely forget the trauma causing such damage, preserved or compensated visual function may blur the patient's memory of these events over time. Characteristic physical findings help to clarify the antecedent history.

The diagnosis and management of orbital blowout fractures: update 2001.

A cogent update of orbital blowout history, anatomy, and management are included with a retrospective study of 59 pure orbital blowout fractures which occurred between 1994 and 1998. Our goal is to provide a better understanding of this frequently encountered entity and to help augment the confidence of nonophthalmologists who will often evaluate patients with suspected orbital blowout fractures.

Monocanalicular intubation for dacryostenosis in oculo-auriculo-vertebral dysplasia (hemifacial microsomia) with congenital corneal anesthesia.

Purpose: To present a case of oculo-auriculo-vertebral dysplasia associated with corneal anesthesia and ipsilateral dacryostenosis that was successfully treated with monocanalicular lacrimal intubation.

Methods: Case report.

Results: Previous neurotrophic corneal ulcers in a child with hemifacial microsomia had become secondarily infected from a stagnant tear lake, resulting in significant corneal scarring and visual loss.

Anophthalmic socket and orbital implants. Role of CT and MR imaging.

The role of CT and MR imaging examination of orbital implants and the anophthalmic socket is expanding constantly. As the imaging techniques gain refinement and resolution, the list of potential clinical application grows. Frequent clinical-radiologic queries regarding the anophthalmic socket include neuro-radiologic findings with congenital anophthalmia or bilateral microphthalmia, the vascularization or position of an orbital implant following enucleation, or orbital recurrence of tumor following enucleation.