EIA Policies in India and its Drawbacks

The second step is Decision Process Model this is putting information in a pattern and

As assessment is usually conducted at two phases in any project. (Burt, 2005) First it is conducted to

Description of the impetus for proposed project, clear demonstration or statement of current practice (i.e. environmental scan) the gap or need identified, and detail of perceived value of project outcome.

The U.S. Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical devices in the context of granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, and post-marketing surveillance of the medical product. Pharmaceutical companies seek FDA approval for a new drug to be marketed which entails a long process. This process starts with submitting an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that the drug is safe and effective.

Once a new drug application is filed, an FDA review team evaluates whether the studies

In this assessment you are required to establish guidelines for researching and gathering information and work with your staff to gather and evaluate the data.

The early process for submitting under the 505(b)2 mechanism includes identifying the compound, determining which pathway to use, setting up a pre-Investigational New Drug (IND) meeting, and meeting with the Food and Drug Administration to determine the appropriate course.

The analysis is the second stage where a review of the ongoing operation is conducted, the future program is validated and expanded, and the forecast of the required facilities is provided and evaluated on how it will suit the market. The analysis will not be full

The applicant (drug sponsor) submits the IND application to FDA. This is reviewed by Center for Drug Evaluation and Research (CDER). They assign specialists from all areas- medical, chemistry, pharmacology, toxicology and statistical to review upon the safety of the drug. In case of absence of deficiencies, the IND application is approved for further study. In case the review board disapproves due to major deficiencies, sponsors are notified who later resubmit

Recommend. This stage involves information gathering and data collection and identification of variances during execution and likely changes that might take place.

In the define phase proposals are formulated, estimated and tested for feasibility. The results will be presented to the senior management in order to receive a "go" for the project which often is in the form of a contract.

This process is similar to an EA conducted by the Agency, except after the final environmental statement is issued, the EA is referred to a review panel. This is followed by the Participation funding application period, during which funding requests can be made, and considered for approval. A comment period is conducted on the draft review panel terms of reference (TOR), a joint public comment period is started if the Agency is working with another jurisdiction which involves a joint review panel. The final TOR is issued, and is followed by the submission of the final environmental impact statement to the Agency, who conducts a completeness review of the statement. If additional information is required, then another

Secondly, to provide an efficient basis for the project comparisons! Business runners use this method to check the complete anticipated expenditure for each aspect against the full expected advantages and to know if the benefits

Initiation: clarifying and recording targets of the project being evaluated, and defining the subtle element of the methodology has to be executed archiving the outcomes in a risk management plan. •

For those projects which are listed under this notification and also attract EIA notification, 2006, for such projects clearance under EIA notification only shall be