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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...

FDA Pathways to Medical Device Approval

Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA...

FDA Solicits Feedback on ANDA Submissions – Amendments to ANDAs Under GDUFA Guidance, Appendix A

Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...

From Idea to Market: The Five Stages of Product Development

The exact product development process for medical devices differs from region to region, with different regulatory expectations that need to be met in the EU, USA, UK and other regions. These precise...

Meet the Expert: Renata Pankiewicz

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...

Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement

Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...

Regulatory Sciences

FDA Publishes Complex Generics News Resource

Today the FDA is publishing a new web page to share the most recent FDA actions and activities related to complex generics. This new resource is part of FDA’s continued commitment to ensuring...

FDA Recognizes August as National Immunization Awareness Month

National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health. The U.S....

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FDA publishes product-specific guidances to facilitate generic drug development

Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...

Regulatory Sciences

UK Paediatric Investigational Plans – what do you need to know?? …and how is it all working in practice??

If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...

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EMA: Big data use for public health: publication of Big Data Steering Group workplan 2022-25

News July 28, 2022 The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. The new...

How to Fast-Track medicine approval in the UK with the MHRA’s Innovative Licensing and Access Pathway (ILAP)

What is ILAP? What benefits does ILAP provide? How do you access it? With the dust of Brexit settling, the question on most people’s lips (well, those of us in the healthcare sector anyway!) was:...

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5 Benefits of Receiving EU PRIME Designation for Medicine Developers

What it is, why it matters, how you can apply and how we can help. What is the PRIME Scheme? You might be forgiven if you don’t know what the PRIority MEdicines (PRIME) scheme is; but if you are in...

7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing

Developing, optimizing, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CAGT) products is extremely complex. The choice of a reliable Contract...

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EMA Good clinical practice (GCP) inspection procedures

The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...

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Orphan Drug Designations in the US and EU

What is an Orphan Drug Designation? The Orphan Drug Designation (ODD) program in both the United States (U.S.) and European Union (E.U.) qualifies sponsors to receive potential incentives to develop...

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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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...

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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...

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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...

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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...