Safety problems Reports

The most important hazard ia the manufacturiag of xanthates is the use of carbon disulfide (qv) because of its low flash poiat, ignition temperature, and its toxicity. A report on the manufacture of sodium ethyl xanthate at Keimecott Nevada Mines Division discusses the various safety problems and the design of a faciUty (81). A plant layout and a description of the reagent preparations are also given. 

Increased Frequency Reports. The requirement for increased frequency reports for serious expected ADRs with marketed products is revoked. This was also published in the Federal Register of 25 June 1997 (Volume 62, Number 122, pp. 34166-34168). The rationale for this was that despite receiving many such reports, only a small number of drug safety problems were identified. 

In the past decade, there has been increased emphasis on drug safety, and more public visibility of safety problems. The volume of reports now exceeds 250000 spontaneous reports per year, and adverse events are highlighted in the medical press and also in the general media. The FDA has released extensive proposed new regulations for post-approval reporting that in part move to harmonise requirements with ICH recommendations for periodic safety update reports (PSURs)... 

Their proposal won FDA approval, the first gene therapy trial everto inject AAV. In June 1999 the clinical team injected the first patient with genetically altered AAV. The procedure was uneventful. Two more patients followed. As the team reported in the March 2000 issue of Nature Genetics, at the suboptimal dose used in the study, meant only to detect manifest safety problems, the first three patients showed no untoward effects and no detectable antibodies [6]. Within 12 weeks after the injec-(Continued on next page)... 

Donn, Jeff. Zicam Not Alone in Side Effect Reports. ABCNews.com. Available online. URL http //abcnewscom/Health/wireStory id=7863 624. Posted June 17, 2009. Problems experienced by users of Zicam, an over-the-counter treatment for colds, reveal a gap in review and approval of drugs by the FDA, according to this Associated Press article. Since a 1938 law passed Congress, homeopathic remedies have not had to go through the approval process of prescription drugs. This article describes some examples of safety problems that have resulted. In the case of Zicam, the... 

Although helium is inert, it is not necessarily pure. An explosion during repurification of air-contaminated helium is reported. Purification was cryogenic and involved a carbon absorber. Liquid oxygen appears to have condensed in the top of the carbon bed, forming a Sprengel explosive, which duly exploded (safety problems were one... 

Rudolf had in fact stated that the use of high concentrations of Zyklon B to reduce execution periods to minutes or seconds, as the witnesses had reported, would mean that there would be safety problems due to explosive concentrations of hydrogen cyanide.649 He had never spoken nor written of a general danger of explosion. 

The warnings about GE food coincided with outbreaks of food safety problems in other parts of the world. For example, mad cow disease (which has nothing to do with GE) was first reported in 1986 in the United Kingdom (UK), shaking confidence in the reliability of regulatory agencies. 

Although cyclohexane oxidation dominates the market, because of cheaper raw materials, the hydrogenation of phenol remains competitive, offering better selectivity with fewer environmental and safety problems. In addition, this process allows efficient valorization of phenol-rich wastes from coal industries. Recently built plants make use of this technology, as reported by the engineering group Aker-Kvaerner (www.kvaerner.com, 2004). The availability of low-price phenol is the most important element for profitability. Besides the well-known cumene process, a promising route is the selective oxidation of benzene with N20 on iron-modified ZSM-5 catalyst [12]. In this way, the price of phenol may become independent of the market of acetone. 

Sometimes, however, being in the same class does not prevent a copycat drug form from getting into new dangerous side effects. For example, Baycol was linked with 31 U.S. deathsi but is the only statin—a class of cholesterol-lowering drugs established already for 15 years in the market in tens of millions of patients— with any reported safety problem. 

The Medicines Agency publishes a summary of the authorisation dossiers for all new medicines inspired by the European Product Assessment Report (EPAR) of the EMEA. It organises information on meetings with representatives of various patient organisations and users of the medicines concerning the safety problems of the healthcare products. 

T. J. Lueck, 1982 Report Cited Safety Problems at Plant in India, New York Times, December 11, 1984. 

Safety is the responsibility of WHO staff supervisors and WHO management. It includes reporting of possible hazards and suspected hazards and taking the necessary precautions and implementing safeguards to minimize safety problems. 

In determining whether a possible safety problem is reportable under Section 15, the first question is whether a product defect may exist. The Act itself does not define this term. Nevertheless, the legislative history suggests that Congress intended the concept of defectiveness under the CPSA to be at... 

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