Pharmaceutical Regulatory Affairs: Open Access

Arun Kumar

Publications

• Review Article
  Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU, India and Other Countries
  Author(s): Arun Kumar and Arun NandaArun Kumar and Arun Nanda
  
  Pharmaceutical research and development is an expensive, time consuming and uncertain process that may take 8-10 years to complete. Patent clock starts much before a new drug is approved for marketing and significant amount of time may be lost in the review and approval process by regulatory bodies. So in order to recoup the considerable time and resources invested in the drug development and approval process the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies. There are several official and unofficial methods to extend term of a patent beyond 20 years, Official methods include provisions by some regulatory bodies such as Dat.. Read More»
  DOI: 10.4172/2167-7689.1000185

  Abstract PDF