EU
Regulatory Sciences
March 26, 2024
EU Pharmaceutical Legislation Reform: Where Are We Now?
On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...
General Regulatory
FDA Meetings
February 26, 2024
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
FDA
Regulatory Sciences
February 26, 2024
The Impact of a US Government Shutdown on the Food and Drug Administration
This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...
FDA
BLA
January 26, 2024
Illuminating FDA's 2023 BLA Approvals: A Comparative Analysis
The FDA's Biologics License Application (BLA) approvals in 2023 have marked a significant chapter in medical innovation, embodying precision and transformative therapies. A closer examination of the...
FDA
NDA
January 11, 2024
2023: A New Chapter in FDA Drug Approvals - A Resurgence of Innovation
The year 2023 unveiled an eventful chapter in FDA drug approvals, heralding a resurgence of innovation after a brief decline. This period represented not just a numerical rebound but a meaningful...
MHRA
EMA
January 8, 2024
UK/EU Regulatory Developments Review 2023
Introduction The year 2023 has been remarkable in terms of regulatory developments within the UK and EU, characterised by substantial changes, innovative approvals, and strategic initiatives in the...
Meet the Expert
Regulatory Sciences
December 14, 2023
Meet the Expert: Philip Simonson
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Meet the Expert
Regulatory Sciences
December 6, 2023
Meet the Expert: Clarence Young
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
Market Access
November 27, 2023
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...