Initiators review

R1 - Regulatory Requirement for the Waste R2 - Reduction of Troafment/Disposal Costs R3 - Other Process Cost Reduction R4 - Self-Initiated Review... 

Once the FDA receive the initial submission, an IND reference number is assigned. The application is then passed on to the appropriate review centre either the Center for Drug Evaluation and Research (CDER), or the Center for Biologies Evaluation and Research (CBER). Various experts will then review the submitted documents, the purpose being to ensure that the safety of subjects is not compromised and, in the case of Phase II and III studies, that the quality of study design is scientifically adequate. The FDA are allowed 30 days to complete the initial review, after which the study can commence, provided that it has been approved by an Institutional Review Board (IRB). 

Olofsson, I. Nordin, A. Soderlind, U., Initial Review and Evaluation of Process Technologies and Systems Suitable for Cost-Efficient Medium-Scale Gasification for Biomass to Liquid Fuels, ETPC Report 05-02, University of Umea/Mid Sweden University, Umea, 2005, p. 90. 

Key elements of reactive hazard identification are owner-initiated review, chemistry review, review of unit operations, review of scenarios, definition of required testing, records testing, and interpretation of results for owner. 

Design reviews are conducted to refine requirements. Hazards are introduced to plant operators following laboratory work, EHS review, capital requirements review, and process hazard analysis. Reactivity is addressed during process hazard analysis and the initial review. 

Many of the most significant patenting regions (e.g. Japan, the USA and Europe) are also signatories of the International Patent Cooperation Treaty (PCT). This allows for an initial review of the patent application to be undertaken by a single patent office. The office then provides a summary assessment of this application, which provides an indication of the likely response that would be obtained from individual PCT countries. For many, this initial assessment plays a major role in deciding whether to proceed with the patent application in individual countries. 

A source apportionment study using the receptor model should include interpretation of the chemical data set by both multivariate and chemical mass balance methods The most critical steps in a receptor model study are the initial review of potential source characteristics and the development of an appropriate study plan. 

Need for Periodic Review. Protected both as to the need for and the right to treatment, how can a patient be safeguarded subsequently First, the course of treatment should be periodically reviewed, as already mandated by law or administrative regulation in the majority of states and their institutions. Second, a patient-initiated review mechanism should be formalized in the hospital setting, so that questions and concerns about the course of treatment can be voiced. 

Conform exactly to the paper or electronic logistical/formatting requirements. The initial review of logistical conformity can slow ultimate approval by months. Make certain that all components are present and clearly labeled as required. 

History Initial Reviews Current Revision Date ... 

A study with this many defects could easily have been initially reviewed and shortcomings noted in a few days. 

The reduction in review time and increase in number of approvals have been the result of increased efforts and efficiency at the FDA and the preparation of better NDAs by pharmaceutical companies. Better communication between the FDA and applicants has also contributed to the improvement. In 1993, 26% of the 113 original NDAs were rejected by the FDA during the initial review for completeness. By 1997, the percentage of refuse-to-file actions had decreased to 1.6% for 124 original applications. These efficiencies have also spilled over into the IND arena, resulting in a lower percentage of clinical holds on a higher number of INDs received (16). 

Conducting initial review and continuing review/approval of research. 

The meeting is conducted to uncover any major unresolved problems or issues to identify studies the sponsor is relying on as adequate and well controlled in establishing the effectiveness of the drug to help the reviewers to become acquainted with the general information to be submitted and to discuss the presentation of the data in the NDA to facilitate its review. Once the NDA is filed, a meeting may also occur 90 days after the initial submission of the application to discuss issues that are uncovered in the initial review. 

R1 Regulatory Requirement for the Waste R2 Reduction of Treatment/Disposal Costs R3 Other Process Cost Reduction R4 Self-Initiated Review R5 Other (e.g., discontinuation of product, occupational safety). 

Are process improvement initiatives reviewed with senior management on a periodic basis ... 

Initial review of all domestic cmd foreign drug applications ... 

NICE has an initial review plan for a wide range of products, including many new and existing medicines, medical devices, diagnostic and surgical procedures. 

When the primary technical reviews are completed, each reviewer must pre-pcire a written evaluation of the NDA that presents his or her conclusions and recommendations regarding the application. Under FDA commitments related to PDUFA11, CDER reviewers will be required to notify sponsors of application deficiencies through information request letters cis each reviewing discipline completes its initial review of an application. 

Preliminary environmental review Verified initial review No review... 

Sponsors initially submit their dossiers to a single MS. That MS conducts the initial review, and is termed the reference member state (RMS). When sponsors then request mutual recognition by other MS, the latter are termed concerned member states (CMS). The RMS is selected by the sponsor. 

An autoradiogram in the laboratory notebook from a Western blot was falsely labelled with a piece of tape to misrepresent the data for an unrelated experiment, and the intensity of a band in another autoradiogram was artificially enhanced in response to the initial review of the respective manuscript ... 

Malkin and Kulichikin (1991) initially reviewed the rheokinetics of cured polymers and highlighted the first empirical chemorheological models. They showed that for a simple homogeneous reaction with no diffusion limitations or gel effects for reacting epoxy-resin systems the chemoviscosity could be described by... 

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