regulatory sciences

What to Expect During the NDA Review Process

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

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Mandatory HTAR Implementation in the EU: Part 2

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking...

Ensure Compliance with EU HTA Regulation (HTAR) Guidelines & Implementation

Mandatory EU HTAR Implementation: Part 1

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health...

Beyond the Trifecta: Best Practices for a Successful Promotional Review Committee (PRC) Process

To reduce frustration within a promotional review committee (PRC), the PRC must be a well-oiled machine firing on all cylinders and working at optimum capacity. How does a PRC achieve this? By...

The Trifecta of Promotional Review: What is a PRC & What do They Do?

The mystique of PRC unveiled – what is it and why you need it to assure successful promotional review. You have received approval from the regulators. You have a dynamic sales force in place. They...

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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...

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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...

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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...

Woman typing on a laptop next to a microscope in a medical laboratory.

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...

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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...

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