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Sasich L.D.,Saudi Food and Drug Authority | Sukkari S.R.,1201 North Shore Blvd.
Saudi Pharmaceutical Journal | Year: 2012

On November 18, 2011, the US Food and Drug Administration (US FDA) announced that breast cancer indication for Avastin (bevacizumab) had been withdrawn after concluding that the drug has not been shown to be safe and effective for the treatment of breast cancer. The specific indication that was withdrawn was for the use of bevacizumab in metastatic breast cancer, with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.The US FDAs decision has been met with emotion and confusion among the public and health professionals. The purpose of this article is to review the regulatory history of bevacizumab for breast cancer and to examine the scientific evidence that led to the approval and subsequent withdrawal of this indication. Bevacizumab also provides the opportunity to illustrate the value of free publicly available US FDA reviews that may contain rigorously reviewed unpublished data and analyses and to contrast the decisions made in the US and Europe about bevacizumab and breast cancer. © 2011.


Greenwood K.P.,University of Queensland | Hafiz R.,Saudi Food and Drug Authority | Ware R.S.,University of Queensland | Lambert S.B.,University of Queensland | Lambert S.B.,Queensland Health
Vaccine | Year: 2016

Measles is one of the most contagious human diseases. Administration of the live attenuated measles vaccine has substantially reduced childhood mortality and morbidity since its licensure in 1963. The live but attenuated form of the vaccine describes a virus poorly adapted to replicating in human tissue, but with a replication yield sufficient to elicit an immune response for long-term protection. Given the high transmissibility of the wild-type virus and that transmission of other live vaccine viruses has been documented, we conducted a systematic review to establish if there is any evidence of human-to-human transmission of the live attenuated measles vaccine virus. We reviewed 773 articles for genotypic confirmation of a vaccine virus transmitted from a recently vaccinated individual to a susceptible close contact. No evidence of human-to-human transmission of the measles vaccine virus has been reported amongst the thousands of clinical samples genotyped during outbreaks or endemic transmission and individual case studies worldwide. © 2016 Elsevier Ltd.


Al-Shammari B.,Saudi Food and Drug Authority | Khalifa M.,King Saud University | Bakheet S.A.,King Saud University | Yasser M.,King Saud University
Oxidative Medicine and Cellular Longevity | Year: 2016

Amiodarone- (AM-) induced pulmonary toxicity (AIPT) is still a matter of research and is poorly understood. In attempting to resolve this issue, we treated Sprague-Dawley rats with AM doses of 80 mg/kg/day/i.p. for one, two, three, and four weeks. The rats were weighed at days 7, 14, 21, and 28 and bronchoalveolar lavages (BAL) were obtained to determine total leukocyte count (TLC). For each group, lung weighing, histopathology, and homogenization were performed. Fresh homogenates were used for determination of ATP content, lipid peroxides, GSH, catalase, SOD, GPx, GR activities, NO, and hydroxyproline levels. The results showed a significant decrease in body weight and GSH depletion together with an increase in both lung weight and lung/body weight coefficient in the first week. Considerable increases in lung hydroxyproline level with some histopathological alterations were apparent. Treatment for two weeks produced a significant increase in BAL fluid, TLC, GR activity, and NO level in lung homogenate. The loss of cellular ATP and inhibition of most antioxidative protective enzymatic system appeared along with alteration in SOD activity following daily treatment for three weeks, while, in rats treated with AM for four weeks, more severe toxicity was apparent. Histopathological diagnosis was mostly granulomatous inflammation and interstitial pneumonitis in rats treated for three and four weeks, respectively. As shown, it is obvious that slow oedema formation is the only initiating factor of AIPT; all other mechanisms may occur as a consequence. © 2016 Bader Al-Shammari et al.


PubMed | Zagazig University, Saudi Food and Drug Authority, Indian Institute of Technology Guwahati and King Faisal University
Type: Journal Article | Journal: Avian pathology : journal of the W.V.P.A | Year: 2016

Newcastle disease (ND) is a highly devastating disease for the poultry industry as it causes high economic losses. In this present study, a DNA vaccine containing the F and HN surface antigens of a highly virulent Newcastle disease virus (NDV), NDV/1/Chicken/2005 (FJ939313), was successfully generated. Cell transfection test indicated that the vaccine expressed the F and HN genes in Hep-2 cells. The main objective of this study was to compare the extent of protection induced by DNA vaccination after homologous and heterologous NDV-challenge as determined by the amount of NDV shedding after challenge. NDV-antibody-negative chickens were vaccinated either once, twice or thrice intramuscularly at 7, 14 and 21 days old and were challenged 14 days post vaccination with either homologous virus (vaccine-matched velogenic viscerotropic Newcastle disease virus (vvNDV) strain, FJ939313), phylogenetically related to group VII, or a phylogenetically divergent heterologous virus (unmatched vvNDV strain, AY968809), which belongs to genogroup VI and shows 84.1% nucleotide similarity to the NDV-sequences of the DNA vaccine. Our data indicate that birds, which received a single dose of the DNA vaccine were poorly protected, and only 30-40% of these birds survived after challenge with high virus shedding titre. Multiple administration of the DNA vaccine induced high protection rates of 70-90% with reduced virus shedding compared to the non-vaccinated and challenged birds. Generally, homologous challenge led to reduced tracheal and cloacal shedding compared to the heterologous vvNDV strain. This study provides a promising approach for the control of ND in chickens using DNA vaccines, which are phylogenetically closely related to the circulating field strains.


PubMed | Cairo University, Saudi Food and Drug Authority, Central Veterinary Laboratory and Zagazig University
Type: Journal Article | Journal: Veterinary world | Year: 2016

The aim of this study was to demonstrate the genomic features of Meq gene of Mareks disease virus (MDV) recently circulating in Saudi Arabia (SA).Two poultry flocks suffering from mortalities and visceral tumors were presented to the Veterinary Teaching Hospital, King Faisal University, SA. Subjected to different diagnostic procedures: Case history, clinical signs, and necropsy as well as polymerase chain reaction followed by Meq gene sequence analysis.Case history, clinical signs, and necropsy were suggestive of MDV infection. The Meq gene was successfully detected in liver and spleen of infected chickens. A 1062 bp band including the native Meq ORF in addition to a 939 bp of S-Meq (short isoform of Meq) were amplified from Saudi 01-13 and Saudi 02-13, respectively. The nucleotide and deduced amino acids sequences of the amplified Meq genes of both Saudi isolates showed distinct polymorphism when compared with the standard USA virulent isolates Md5 and GA. The sequence analysis of the S-Meq gene showed a 123 bp deletion representing 41 amino acids between two proline-rich areas without any frameshift. The Meq gene encoded four repeats of proline-rich repeats (PRRs sequences), whereas the S-Meq contains only two PRRs. Interestingly, the phylogenetic analysis revealed that both of SA MDV isolates are closely related to the MDV strains from Poland.The two MDV isolates contain several nucleotide polymorphisms resulting in distinct amino acid substitutions. It is suggested that migratory and wild birds, as well as world trading of poultry and its by-products, have a great contribution in the transmission of MDVs overseas.


PubMed | Center for Innovation in Regulatory Science, King Saud University, Saudi Food and Drug Authority and University of Cardiff
Type: | Journal: Pharmaceutical medicine | Year: 2016

This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence.A questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same timeframe (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapores Health Sciences Authority, and Australias Therapeutic Goods Administration.All four regulatory agencies have established target times for scientific assessment and regulatory review, examine dossier sections in parallel, and separate company response time from overall timing. Additionally, all four agencies have instituted good review practices including standard operating procedures, templates, dossier monitoring, and continuous improvement processes, and assign a high priority to transparency in their relationships with the public, healthcare professionals and industry. Of the four agencies, however, only the SFDA requires a Certificate of Pharmaceutical Product (CPP) at the time of the submission and pricing negotiations before final product approval.To assist the SFDA in its efforts to become a Regional Centre of Excellence, it is suggested that the agency explore a risk stratification approach to select dossiers for verification, abridged, or full reviews; use forms of certification other than the CPP; make pricing negotiations independent to the review process; and introduce a feedback process for the quality of the dossier.


PubMed | King Saud University and Saudi Food and Drug Authority
Type: | Journal: Oxidative medicine and cellular longevity | Year: 2016

Amiodarone- (AM-) induced pulmonary toxicity (AIPT) is still a matter of research and is poorly understood. In attempting to resolve this issue, we treated Sprague-Dawley rats with AM doses of 80mg/kg/day/i.p. for one, two, three, and four weeks. The rats were weighed at days 7, 14, 21, and 28 and bronchoalveolar lavages (BAL) were obtained to determine total leukocyte count (TLC). For each group, lung weighing, histopathology, and homogenization were performed. Fresh homogenates were used for determination of ATP content, lipid peroxides, GSH, catalase, SOD, GPx, GR activities, NO, and hydroxyproline levels. The results showed a significant decrease in body weight and GSH depletion together with an increase in both lung weight and lung/body weight coefficient in the first week. Considerable increases in lung hydroxyproline level with some histopathological alterations were apparent. Treatment for two weeks produced a significant increase in BAL fluid, TLC, GR activity, and NO level in lung homogenate. The loss of cellular ATP and inhibition of most antioxidative protective enzymatic system appeared along with alteration in SOD activity following daily treatment for three weeks, while, in rats treated with AM for four weeks, more severe toxicity was apparent. Histopathological diagnosis was mostly granulomatous inflammation and interstitial pneumonitis in rats treated for three and four weeks, respectively. As shown, it is obvious that slow oedema formation is the only initiating factor of AIPT; all other mechanisms may occur as a consequence.


PubMed | King Saud bin Abdulaziz University for Health Sciences, Saudi Arabian Anti Doping Committee, King Saud University, Saudi Food and Drug Authority and South Armed Forces Hospital
Type: | Journal: Substance abuse treatment, prevention, and policy | Year: 2016

To estimate the lifetime prevalence and address the attitudes and knowledge of using prohibited substances (doping) among sport players in Saudi Arabia.A cross-sectional survey carried out using systematic random sampling technique among Saudi players of variable sports attending the sport clubs, stadiums, and sport fields (70 sport clubs, 22 types of sports belong to 22 Saudi sport federations were visted in 18 cities from all regions of Saudi Arabia).A total of 1142 male sport players were interviewed with main age of 24. The prevalence of using prohibited substances (doping) was 4.3%. The main reason for using prohibited substances was to improve performance (69%). The prevalence of using food supplements (not prohibited) was 38.4%. Among the players, 30% of them believe that such behavior is against the spirit of sport while 70% of the players are aware of punishment against doping. 65% of players admitted that they received advice on prohibited substances. Higher rate of using prohibited substances (doping) among Saudi players was associated with low education, age below 20years, previous use of food supplements and lack of punishment awareness.Using prohibited substances (doping) among Saudi sport players is common. Players believe that such use is against the spirit of the sport and they are aware about its punishment, despite this, they are still using prohibited substances.


PubMed | University of Queensland and Saudi Food and Drug Authority
Type: Journal Article | Journal: Vaccine | Year: 2016

Measles is one of the most contagious human diseases. Administration of the live attenuated measles vaccine has substantially reduced childhood mortality and morbidity since its licensure in 1963. The live but attenuated form of the vaccine describes a virus poorly adapted to replicating in human tissue, but with a replication yield sufficient to elicit an immune response for long-term protection. Given the high transmissibility of the wild-type virus and that transmission of other live vaccine viruses has been documented, we conducted a systematic review to establish if there is any evidence of human-to-human transmission of the live attenuated measles vaccine virus. We reviewed 773 articles for genotypic confirmation of a vaccine virus transmitted from a recently vaccinated individual to a susceptible close contact. No evidence of human-to-human transmission of the measles vaccine virus has been reported amongst the thousands of clinical samples genotyped during outbreaks or endemic transmission and individual case studies worldwide.


LIVINGSTON, NJ--(Marketwired - November 30, 2016) - Milestone Scientific Inc . ( : MLSS), a medical R&D and dental products company that designs, patents, incubates and commercializes a growing portfolio of innovative therapeutic injection technologies, today announced it has entered into a distribution agreement with Al-Hayat, in the United Arab Emirates (UAE). Milestone and Al-Hayat introduced the epidural instrument and disposable kit to approximately 30 anesthesiologists from the UAE, at the Pan Arab Congress of Anesthesia, at two product launch meetings in Dubai and Al Ain. Milestone Scientific also announced it has launched the epidural instrument and disposable kit in Lebanon with its distributor, Sterimed, and is now proceeding with product evaluations at five hospitals in Lebanon. Milestone has also received the required Authorized Representative (AR) license approval by the Saudi Food and Drug Authority, which is required for device registration in order to allow Milestone's distributor to import and commercialize the epidural instrument in Saudi Arabia. Incrementally, Milestone has signed distribution agreements in Egypt and Kuwait, as part of its Middle East product launch strategy. Milestone also announced that it will be replacing its Polish distributor and that its new marketing and sales team is undertaking an evaluation of potential new distributors. Milestone will be exhibiting its epidural instrument and disposable kit at the Arab Health Exhibition & Congress in Dubai from January 30 to February 2, 2017, the largest healthcare exhibition and medical congress in the Middle East and the second largest healthcare exhibition and congress in the world. The exhibition is an important venue for meeting with Middle Eastern distributors and key opinion leaders. Leonard Osser, Chief Executive Officer of Milestone Scientific, stated, "We are pleased with the progress we have made developing distribution partnerships in the Middle East and have received positive feedback from key opinion leaders in the region. Placing the epidural instrument and disposable kits with distributors and key opinion leaders is central to our strategy, now that we have completed our clinical trials in the United States. We are awaiting US FDA approval of the epidural instrument and disposable kits, which will provide further validation for medical practitioners around the world." Milestone Scientific Inc. (MLSS) is a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. For more information please visit our website: www.milestonescientific.com. This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2015. The forward looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

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