Background: The Abbreviated New Drug Application commonly referred as ANDA is an application that contains data submitted to US FDA for the review and prospective marketing authorization of generic drugs. The conduct of the reviewing of the application is done by the Division of Filing Review (DFR), Office of Regulatory Operations (ORO) in the Office of Generic Drugs (OGD). The format of ANDA: USFDA recommends the submission of ANDA applications as per ICH Common Technical Document (CTD) format. Module 3: Module 3 of CTD contains Chemistry, Manufacturing and Control (CMC) information including all the supporting details verifying that was summarised in section 2.3 which is the quality overall summary. Evaluation of ANDA: For the evaluation of an Abbreviated New Drug Application in the US, its Office of Generic Drugs (OGD) has developed a Question-based Review (QbR) for its CMC section which is mainly focussed on the critical quality attributes. Conclusion: The implementation of Questionbased Review programme is yielding good improvements in FDA's division of Office of Generic Drugs (OGD), i.e., by advancing the review pattern of the ANDA CMC section without compromising quality and efficacy for the indication of the generic product.

-Textile industry is one of the major industries responsible for water pollution with dyes and pigments which are indispensable in modern era and have found wide location in fabrics, home interiors, leather accessories, plastics, automobiles and paper industry. Wastewater are reduced by textile dyeing and finishing operation which is characterized by highly intensive color, high Chemical Oxygen Demand (COD) and low biodegradability. For the present investigation of treating textilewastewater sampling was made from KSIC, Karnataka. Characterization of textile wastewater subjected to study revealed a high chemical oxygen demand (COD) in the range of 1750 to 4320mg/L, nitrate 40 to 80mg/L, phosphate 40 to 70mg/L, sulphate 48 to 125mg/L, solids 1200 to 1400mg/L, turbidity 390NTU, pH 6.2 to 8.83. The Biochemical oxygen demand (BOD5@27°c) for this orders of lower than COD (100-120mg/L). In addition to this textile wastewater is usually hot and alkaline, with strong smell and color due to the use of dyes and chemicals, low biodegradability makes the environment for biological degradation more difficult and expensive. Since textile wastewater has high COD and low BOD, the present study was undertaken with the aim of developing complete treatment technology for the treatment of textile wastewater by physico chemical method such as Electrochemical and ElectroFenton methods at laboratory scale. Electrochemical treatment of textile wastewater using stainless steel as electrode material of size 5cm × 5cm, distance between the electrodes maintained at 1cm, with the optimum of 12volt resulted in COD reduction of 84.0% and color removal of 99.0% were obtained. Electro-Fenton method was studied using stainless steel as electrode material and with external addition of Hydrogen peroxide there by stimulating typical Fenton reaction by conducting series of experiments with 1L working capacity Batch reactor. Aiming selection of the best operating conditions RPM, H 2 O 2 , several studies were carried out with preliminary study initially with lowest measurable H2O2 dosage of 0.1ml/L, with increment of 0.1ml/L for every next dosage. The optimal conditions of the study were found to be 0.2ml/L hydrogen peroxide of Fenton dosage at mixing speed of 250 RPM for a reaction period of 90minutes which resulted in COD reduction of 84% and color removal of 98% were obtained.