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  • adverse
  • The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIMâ„¢ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period. (clinicaltrials.gov)
  • Humans
  • His research spans mechanisms of tobacco addiction including patterns of tobacco use, development of unobtrusive and minimally invasive measures of tobacco exposure in humans, and ways to communicate effectively with consumers about tobacco products. (roswellpark.org)
  • Drugs
  • As you may know, one of Dr. Jane E. Henney's first initiatives after being sworn in as Commissioner of Food and Drugs was to establish a Task Force 1 to evaluate the system for managing the various risks of FDA-approved medical products. (vegaslawyer.net)
  • While today's hearing is focusing on adverse events associated with human drugs, I would like to note that use of other medical products such as medical devices and biologicals, also involves risk. (vegaslawyer.net)
  • practice
  • Usual practice plus community surveillance for TI cases and treatment at 6 months: The three villages randomized to this arm would receive mass treatment, similar to the usual practice arm, but in addition, would have a cadre of community volunteers, trained to recognize TI. (bioportfolio.com)
  • Intervention 2: Usual practice plus community surveillance for TI cases and treatment every 4 months: The three villages randomized to this arm would have an approach identical to intervention 1, but with surveillance and treatment of TI cases at 4 and 8 months instead of at 6 months.For the second year, they would have surveillance and treatment at 6 months. (bioportfolio.com)
  • To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy of the drug. (clinicaltrials.gov)
  • Identify
  • This process of detection, called medical surveillance, is conducted to identify changes in the distribution of diseases, thereby permitting their prevention or control within the population. (mhmedical.com)
  • Although extensive studies are required for licensure of new vaccines, post-marketing research and surveillance are necessary to identify safety issues that may only be detected following vaccination of a much larger and more diverse population. (fda.gov)
  • Evaluate
  • FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. (fda.gov)
  • tobacco products
  • Other work focuses include: impact of tobacco policy on product use, assessment of consumer interest in novel tobacco products as substitutes for cigarettes, and the development of unobtrusive methods for assessing smoke exposure. (roswellpark.org)
  • The laboratory also houses the International Tobacco Product Repository, which is creating cohort surveillance of popular tobacco products in a number of countries. (roswellpark.org)
  • Support for this project was provided by the Food and Drug Administration (FDA) prior to the March 2000 decision by the Supreme Court denying FDA comprehensive authority over tobacco products. (nap.edu)
  • regulatory
  • His program of research focuses on building the evidence base for tobacco regulatory science, with a particular focus on product-user interactions. (roswellpark.org)
  • Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market. (fda.gov)
  • FAERS
  • FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and responding to outside requests for information. (fda.gov)
  • The reports in FAERS are evaluated by clinical reviewers, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), to monitor the safety of products after they are approved by FDA. (fda.gov)
  • liability
  • He is also a project director on the NCI-funded Consortium on Methods for Evaluating Tobacco (COMET), which is working to develop state-of-the art methods for assessing tobacco product abuse liability, consumer perceptions, and toxicity. (roswellpark.org)
  • Also, you can get an overview of other claims like Wrongful Death , Auto Accidents , Slip & Fall , and Products Liability before you explore the Article below. (vegaslawyer.net)
  • study
  • The term population-based means that the target group under study or surveillance is the general population, usually in terms of geographic residence. (mhmedical.com)
  • Pipeline
  • The consequences have been a stagnant industry pipeline and a decrease in revenue- generating products, which, in turn has resulted in significant R&D personnel lay-offs. (ddw-online.com)
  • provide
  • The Tobacco Research Laboratory, which Dr. O'Connor directs, works to characterize popular products sold on the international market in terms of physical and design features, so as to provide greater insight into user-product interactions that may affect addiction and/or health outcomes. (roswellpark.org)
  • risk
  • Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. (endo.com)
  • community
  • infection at one, two, and three years, relative to the added costs, of community-based surveillance and treatment of cases of severe trachoma (TI) semi-annually or every 4 months? (bioportfolio.com)
  • problems
  • epidemics that could kill a large part of a population and to maintain health surveillance of a population so that new diseases and problems could be recognized. (mhmedical.com)
  • A great variety of information is collected during surveillance, including demographic information about affected and unaffected individuals, their behaviors, and the geographic location of health problems. (mhmedical.com)