With a laser-like emphasis on results and value, healthcare is fast moving to a new world of patient choice. Indeed, healthcare systems that have historically emphasized medical treatments based on episodic interactions with patients are now realizing the need to fully comprehend external variables and provide ongoing care. Exogenous factors like genomics, conduct and social […]
Expanded use of RWE (Real World Evidence) Read More »
One of the fastest-expanding technologies on the planet at present is Artificial Intelligence (AI) in the pharma Industry. It has been gaining so much popularity lately that even industries and sectors have applications and use cases for it. Even from smart factories using AI to ramp up their production efforts, to the smart assistant in
Artificial Intelligence – Impact on The Global Pharma Industry Read More »
IDMP is a progression of five specific guidelines established by the International Organization for Standardization (ISO) that emphasize different identification standards in the pharma industry. These standards establish an internationally recognized framework for uniquely identifying and describing pharmaceutical items, as well as for standardized documentation, coding and product information interchange across global regulators, manufacturers, suppliers
Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA Read More »
The US Food and Drug Administration (FDA) has recently finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence (CC) process. This guidance finalizes the draft guidance issued in Nov 2017 and replaces the finalized guidance issued in September 2015. This update on controlled correspondence with FDA
Controlled Correspondence with FDA – An Update Read More »
The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug prescriptions dispensed. On August 18, 2017, the President of the USA signed into law the Food and Drug Administration Reauthorization Act (FDARA) including the reauthorization of the Generic Drug User
Generic Drug User Fee Amendments Read More »
The pharmaceutical industry is one of the most important industries that will be directly impacted by Brexit. When the United Kingdom’s referendum was held in June 2016, the majority of the British electorate voted for the withdrawal of the UK from the European Union (EU) and now Brexit is a reality. Brexit and its potential
Impact of Brexit on the Pharmaceutical Industry Read More »
In July 2018, the European medicines regulatory network became aware of the presence of nitrosamine impurities in an Active Pharmaceutical Ingredient (API). This was the first time that a nitrosamine impurity had been detected in a pharmaceutical drug. The unexpected delivery of these impurities resulted in voluntary product recalls on a mass scale and led
Nitrosamine Impurities: A Regulatory Perspective Read More »
