Drug approval

>Tag:Drug approval
24 01, 2013

Enrichment Strategies for Clinical Trials

By | 2016-10-12T14:35:11+00:00 January 24th, 2013|Categories: News|Tags: , , , , , , , , , |

Author: Steve Kates, Ph.D. A draft guidance has recently been issued (Dec 2012) entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” The document required more than 6 years to prepare and provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims. This guidance outlines three enrichment strategies. 1. Strategies to decrease heterogeneity [...]

15 09, 2011

Delays in licensing approvals in India

By | 2016-10-10T17:05:59+00:00 September 15th, 2011|Categories: News|Tags: , , , |

Marketing licenses for biotechnological drugs as well as those used in clinical trials are being rejected by India’s apex pharmaceutical regulator, known as the DCGI, or Drugs Controller General of India. In the last year they have tightened the mechanism for approval on all fronts for therapeutic agents. Both domestic and multinational companies are facing much regulatory scrutiny and are often asked to make some changes in order to be [...]