IMPORTANCE OF DEFICIENCY RESPONSE IN PHARMACEUTICAL ENVIRONMENT FOR DRUG APPROVAL
Journal Title: International Journal of Drug Regulatory Affairs - Year 2014, Vol 2, Issue 4
Abstract
This illustrates examples of series deficiencies, that’s how really company faces problem due to deficiency. It’s to convey the message if drug product manufacturer can visualize earlier all aspect of risks and manifest proactively, then there is always least chance to have the said deficiency received. However, even then if company also gets deficiency, company could have equipped with earlier data. So, what they need to do is to focus properly for addressing agency’s query by utilizing proper scientific and technical writing skills. How lack of visualization creates problem, how review cycle prolonged and how by dint of this issue approval got delayed has been clearly discussed in this case study. The reason of so many rounds of questions and review cycles become longer and finally approval got delayed is from the beginning itself agency was not satisfied or convinced with the justification given by said Company.
Authors and Affiliations
Swagat Tripathy, Murthy P. N
Keywords
Related Articles
- EP ID EP343063
- DOI -
- Views 96
- Downloads 0
FORMULATION AND IN VITRO EVALUATION OF EXTENDED RELEASE MATRIX TABLETS OF LEVOSULPIRIDE BY USING NATURAL POLYMERS
The aim of the present study was to develop sustained release formulation of Levosulpiride to maintain constant therapeutic levels of the drug for over 12 hrs. By using various Natural polymers like Fenugreek, Almond gum...
Regulation of Medicines in Bhutan: Current Status, Challenges and Opportunities
Medicines Regulatory Agencies (MRAs) are responsible for evaluation of quality, safety and efficacy of medicinal products before it is approved for consumption. The regulatory procedures, however, differs from one countr...
Establishment of blending control for Hand operated Double Cone Blender
In the current study, a fundamental approach is used to establish operation procedure, for a hand operated double cone blender. Initially, assuming for a potent drug, where in, the strength of the drug is very less in t...
CLINICAL TRIAL IN INDIA: RISE AND FALL
Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices through clinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, tes...
Drug approval process in US, Europe and India and its regulatory requirements: A Review
Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expr...