New Drug Application

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Drug Approval Process For US, Europe and India

Currently different countries have to follow different regulatory requirements for approval of new drug. For marketing authorization application (MAA) a single regulatory approach is applicable to various countries is almost a difficult task. Therefore it is necessary to have knowledge about regulatory requirement for MAA of each country.

This article focuses on drug approval process in different countries like USA, Europe and India.

FDA Approves Momentous New Indications for Xarelto

Last month the U.S. Food and Drug Administration (FDA) approved rivaroxaban (Xarelto), a factor Xa inhibitor, for the treatment and prevention of acute deep vein thrombosis (DVT) and pulmonary embolism...making it the first oral anti-clotting drug approved for the treatment of blood clots since warfarin (Coumadin) almost 60 years ago.

Oral strip technology; an overview (audio blog)

Oral strip technology; an overview

Hello and welcome to my audio blog,
In this oral blog I present an overview on oral strip technology
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It includes following information
1)An introduction to novel drug delivery giving the importance of oral films…

Preclinical Studies in Drug Development

Hi Friends, my first blog for this month is regarding Preclinical studies in Drug development. After its discovery in the laboratory every New Chemical Entity NCE)should face a series of challenges/trials to make its way into the market successfully. The entire drug development process can be divided into the following steps: [1] 1. Preclinical Studies/Trials

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