Scientific evaluation process

The applicant must submit complete copies of dossier to the EMEA, and directly to each of the rapporteurs. The EMEA are allowed 14 days to validate the application to ensure that it is complete and in accordance with the regulations, after which the rapporteurs can commence the scientific evaluation. The review process involves considerable feedback between the rapporteurs, the CHMP and the applicant, central to which can be achieving agreement on the final text of the SPC, labels and leaflet. The rapporteurs are required to deliver preliminary assessment reports to the CHMP within 80 days of the start of the review process. The applicant is also copied on the report. Over the next 40 days issues raised in 

Assuming that the outcome is favourable, the agency must forward its opinion to the applicant, the EU Commission and the Member States within 15 days, together with  

If the opinion is unfavourable, the applicant has 15 days to notify the agency of its intention to request a re-examination of the decision, and a further 45 days to submit the grounds on which a review is requested. New rapporteurs are appointed to re-examine the dossier, and the C H M P is allowed 60 days to deliver its opinion in light of the re-examination. 

---

The importance of U.S. tolerances stems from both the stringency of the scientific evaluation process upon which they are based and the important role of the U.S. in international food trade. Some countries actually defer to U.S. tolerances in lieu of their own legislation for export purposes (e.g., Costa Rica, Mexico). It is expected that U.S. tolerances will be highly influential in future development of MRL policy within the NAFTA countries, particularly as regional harmonization efforts may some day lead to a system of NAFTA MRLs. The FQPA-mandated tolerance reassessment process has resulted in many changes in U.S. tolerances, particularly the loss or reduction of tolerances for some older products, and these changes have the potential to impact use and food export practices in U.S. trading partners. 

The FDA has continuously reevaluated GRAS substances for safety. The evaluation process looks at all scientific data available on the ingredient s safety as well as the historical use of the ingredient. Substances that have been... 

The PMA evaluation process, unlike the 510(k) process, is intended to establish intrinsic safety and effectiveness of a device, rather than comparability with a legally marketed predicate device. For PMA, the performance characteristics of a device must be established as a stand-alone application. In order for an IVD PMA to be approved, the sponsor must demonstrate that the device has clinical utility and that it is safe and effective for its intended use. Generally, the agency bases its determination of clinical utility on whether the device is recognized widely by health practioners or supported by peer-reviewed scientific literature as having reasonable clinical utility or usefulness. The PMA is the more stringent of... 

Moore JA (1995) An assessment of lithium using the IEHR evaluative process for assessing human development and reproductive toxicity of agents. IEHR Expert Scientific Committee. Reprod Toxicol, 9 175-210. 

The subcommittee recommends that the evaluative process be implemented by a team of scientists with training and experience in assessing agents for their potential to cause reproductive and developmental toxicity. Such evaluation requires expertise in the intricacies and relationships of the integrated processes of reproduction and development. Considerable scientific judgment is needed to interpret data and make informed decisions about the adequacy of available data sets for estimating the potential reproductive and developmental toxicity of specific substances under specific conditions of exposure. 

To demonstrate how the subcommittee s recommended evaluative process can be applied to specific agents, the subcommittee evaluated two compounds of interest to the Navy jet propulsion fuel 8 (JP-8) and hydrofluorocarbon (HFC) 134a. These assessments demonstrate that the subcommittee s recommended process can be used to evaluate compounds for which varying amounts of data are available. For example, several reproductive and developmental toxicity studies have been conducted for HFC 134a however, just one developmental toxicity study has been conducted for JP-8. The subcommittee calculated a UEL based on at least one endpoint for each compound, accounting for uncertainties due to deficiencies in the database. Regardless of the quantity of data available, the subcommittee found that considerable scientific judgment was needed to conduct the evaluations. 

The evaluative process uses both scientific data and scientific judgment. The data required to identify an agent as toxic should... 

CTs with prospective new medicines must be authorized by the competent MRA before started. In addition to the scientific evaluation, another prerequisite for the authorization is an approval of the protocol and the trial site by the competent Ethics Committee. The GCP must be obeyed and its compliance monitored by governmental inspectors. Maximal processing time of CT applications is 60 days, a period within which there is not more than 42 days for the ethical approval. 

Toxicology, and particularly the portion of it associated with the assessment of commercial products for safety, is philosophically a conservative scientific practice. If a choice is to be made as to whether to accurately identify human hazard or to over-predict any hazard, with both predictions having a degree of uncertainty, the latter course will be chosen. Likewise, if an evaluation process, which is dated but very familiar is challenged by a new technology which is scientifically, economically, and ethically superior but with which there is no precedent or prior history of use, the former will be selected. Both of these two choices are made with reference to what... 

Transformation of different polyoxyalkylene diols and triols with ammonia to the corresponding primary amines is of great practical importance. The results have been disclosed almost exclusively in the patent literature a summary can be found in a previous review [26], The catalyst of choice is Raney Ni or supported Ni, modified with selectivity and stability promoters such as Fe, Co, Cr, or Mo. The use of a non-porous or mesoporous support is essential to enable access of the bulky reactants to the active sites. Scientific evaluation of these processes is, unfortunately, difficult on the basis of the information available. At best, the conversion is estimated from the amount of water formed and the ratio of primary to secondary amines is determined. On the basis of these data the yields of primary amines are excellent, reaching 85-90%. It seems that selectivity is barely affected by the conversion, in contrast with general observation in the amination of short-chain alcohols and diols [3,4,14]. 

---