thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence

Access to trustworthy pharmaceutical information is essential for patient safety and informed decision-making. In the Netherlands, medical information (MI) services are central to this goal, providing healthcare professionals, patients, and caregivers with accurate, non-promotional product...

Healthcare professional using mobile tablet at a patient's home

Why Partner with a CRO that has In-House DCT Capabilities?

When you need to outsource your clinical trials and decentralized visits, it can be beneficial to select a single provider that can do both. There are many synergies that come from using a single...

Hands holding a medicine bottle.

FDA Issues Final Guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The recommendations for prescription drug and...

FDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

The FDA’s Office of Clinical Pharmacology within the Office of Translational Sciences released a new draft guidance document that, for the first time, clearly addresses the FDA’s recommendations and...

Gloved hands holding up vials over a laptop keyboard.

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision

Guidance for Industry May 2022 Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this...

Meet the Expert: Toby Odenheim

Meet the Expert: Toby Odenheim

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: Steven Silverman

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...

Autism Awareness: Advancing Early Diagnosis in Children

Did you know that 1 in 44 American children is autistic, and approximately 5.4 million adults in the U.S. are autistic as well? It's an extraordinarily diverse group too, as autism spectrum disorder...

Annex 21: What You Need to Know

It’s finally here, a guidance on how to handle medicinal products imported from outside EU/EEA. If you’ve ever wondered what the expectations are on these imported medicinal products, you’re in for a...

Clinical Research Solutions

7 Questions to Ask When Selecting a DCT Provider

When considering a decentralized approach to your clinical trial, it can be confusing or overwhelming to identify a provider that will truly understand and support specific study needs. ProPharma...

Meet the Expert: Jeff Block

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...

Diagram showing the different decentralized clinical trial approaches for patients.

4 Steps to Decentralize Clinical Trials

Decentralized Clinical Trials (DCTs) is a buzzword in the clinical research space that has been gaining notoriety because of the COVID-19 pandemic. It’s a concept that revolves around bringing...

Meet the Expert: Raphael Richarz

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...

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Regulatory Sciences

FDA's Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

Meet the Expert: Shelby Stillwagon

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: James Meckstroth

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...

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...

Hands working on a laptop.

FDA's Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

Healthcare worker showing a woman details on a tablet device.

What are Patient Support Programs?

Patient Support Programs (PSPs)  in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...

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Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...

Low angle of the United States Capitol Building

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...

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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...