In this paper, we focus on the design of transmit waveforms a frequency diverse array (FDA) in order to improve output signal-to-interference-plus-noise ratio (SINR) presence signal-dependent mainlobe interference. Since classical multi-carrier matched filtering-based FDA receiver cannot effectively utilize waveform diversity FDA, novel framework based multi-channel mixing and low pass filterin...

Objective To investigate the effect of including unpublished trial outcome data obtained from the Food and Drug Administration (FDA) on the results of meta-analyses of drug trials. Design Reanalysis of meta-analyses. Data sources Drug trials with unpublished outcome data for new molecular entities that were approved by the FDA between 2001 and 2002 were identified. For each drug, eligible syste...

BACKGROUND Decreasing the microbial skin burden reduces the risk of surgical site infection (SSI). The present study compares the activity of an innovative 2% chlorhexidine gluconate (CHG)-impregnated preoperative skin preparation cloth (PC) with a standard application procedure with a 4% CHG surgical skin preparation (SP). METHODS A paired, randomized, parallel phase III study was conducted ...

PURPOSE To compare clinical outcomes of metastatic head and neck cancer patients treated in phase I clinical trials with clinical outcomes of those patients who had their last Food and Drug Administration (FDA)-approved therapy in the setting of metastatic disease. EXPERIMENTAL DESIGN We retrospectively reviewed the outcomes of 61 consecutive patients with head and neck tumors treated in 36 p...

I had the privilege of serving at the US Food and Drug Administration (FDA) for 7 years and helping oversee the agency ’s 1994e1996 investigation of the tobacco industry. That effort enabled FDA to assert jurisdiction over cigarettes and smokeless tobacco products. From 1997 to 2000, FDA began to regulate these products and enforce certain youth access restrictions. In March 2000, after a lawsu...

Methods We conducted a retrospective, longitudinal study evaluating patients with AR, over the age of three, who were using SCIT with extracts of D pteronyssinus (Dp) and/or B tropicalis (Bt) (FDA Allergenic). Data were collected through interviews and medical records. The classification of the severity of adverse reactions met the criteria established by the Allergen Immunotherapy: a Practice ...

Conference on Clinical Cancer Research November 2012 Re-evaluating Criteria for Accelerated Approval Richard L. Schilsky, Chief, Section of Hematology-Oncology, University of Chicago Medical Center David P. Schenkein, CEO, Agios Pharmaceuticals Wyndham H. Wilson, Senior Investigator, Chief, Lymphoma Therapeutics Section, NCI Cheryl L. Jernigan, Research/Patient Advocate, Susan G. Komen fo...

Submit Manuscript | http://medcraveonline.com Abbreviations: SB: Solvent-Based; Nab-Paclitaxel: AlbuminBound Paclitaxel; FDA: Food and Drug Administration; DHA: Dubai Health Authority; DH: Dubai Hospital; MTD: Maximum Tolerated Dose; AUC: Concentration-Time Curve; PFS: Progression-Free Survival; OS: Overall Survival; ORR: Objective Response Rate; ECOG: Eastern Cooperative Oncology Group; RECIST...

BACKGROUND Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS Available d...