What is new drug development?

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.

What is the status of pharmacovigilance in the present scenario?

ABSTRACT: Pharmacovigilance is now accepted to be a continuous process of evaluation accompanied by steps to improve safe use of medicines which involves pharmaceutical companies, regulatory authorities, health professionals and patients.

What are the issues related to pharmacovigilance?

Pharmacovigilance focuses on drug quality, medication errors and adverse drug reactions which impact the health care system by affecting a significant patient population.

What are the 4 main stages of drug development?

Here’s a breakdown of what the four stages of drug development covers.

  • Discovery and Development. The first step in drug development is discovery.
  • Preclinical Research.
  • Clinical Research.
  • FDA Review.

What are the 4 phases of drug development?

The Drug Discovery Process involves many different stages and series of actions. Typically, it can be divided into four main stages: Early Drug Discovery, Pre-Clinical Phase, Clinical Phases, and Regulatory Approval.

What is triage in Pharmacovigilance?

Triage refers to the process of placing a potential adverse event report into one of three categories: 1) non-serious case; 2) serious case; or 3) no case (minimum criteria for an AE case are not fulfilled).

Who controls pharmacovigilance in India?

Abstract. Pharmacovigilance in India was initiated way back in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India.

What is IND and NDA?

The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category.

What is CRL in FDA?

In some cases, the FDA will issue a sponsor a Complete Response Letter (CRL) in which the agency declines to approve a drug or biologic. However, this is not a disapproval.