Drug Safety

November 25, 2016

Regulatory Reporting Timelines For ICSRs In Pharmacovigilance?

When a healthy volunteer/patient suffers a negative health reaction to a drug being tested in clinical trials, an adverse event is reported and […]
November 23, 2016

What is Adverse Drug Reaction?

When a patient/volunteer being administered a drug under clinical trials or outside trials in the case of a treatment regimen, undergoes an adverse […]
November 14, 2016

What Are the FDA’s New Compounded Drug Guidelines?

The FDA aims to protect the health of U.S citizens’ by assuring them safe and secure drugs as well as biologics. However, the […]
November 1, 2016

What Are The Biggest Biosimilar Challenges?

The term biosimilar refers to a pharmaceutical drug that is similar to an originally approved biological product with significant differences in safety and […]
October 24, 2016

Criteria That FDA Uses In Deciding To Approve A New Drug

There are different phases of developing a new drug. The first phase is a preclinical phase. The duration of this phase lasts for […]
October 12, 2016

Important Drug Development Process!

Developing a new drug takes years of research and testing before it gets approved by FDA. The procedure of FDA approval is lengthy […]
September 29, 2016

Compliances of Drug Safety and Pharmacovigilance

Clinical trials are a part of drug safety procedures for new as well as current drugs that are on sale. This helps to […]
September 19, 2016

What Is Process Analytical Technology (PAT)?

Process Analytical Technology (PAT) is a standard mechanism used by Food and Drug Administration (FDA) to regulate and maintain standards in the process […]
September 15, 2016

How Long Does It Take For The FDA to Review a NDA?

The process of creation of a drug to getting it in a market place is a lengthy process. Every process, right from the […]
September 6, 2016

The Scope of Pharmacovigilance 5 Years from Now

The basis of this profile is to keep an eye on the safety measures of the drugs that enter the market. The evaluation […]
September 1, 2016

Roles and Responsibilities of a Drug Safety Associate

The role of a drug safety associate is very unique. Generally the drug safety associates work in a team, with each one having […]
August 25, 2016

How Important Is It To Become Proficient In Medical Narrative Writing?

Reporting is meant to be simplified so that the professional who reads the reports related to health care gets clarity about its content. […]
August 23, 2016

What is Institutional Responsibility?

Every healthcare unit has to follow code of ethics and social responsibilities. The purpose of having this code of ethics and regulations is […]
August 22, 2016

Role of the Drug Safety Associate

In the field of pharmaceuticals, the drug safety associate is used to collect, process, and analyze the new and marketed products for its […]