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FDA Launches Crackdown on Deceptive Drug Advertising
Signal Detection and Management - The Pursuit of Safer Products
Signal detection for products in development Why signal detection in clinical development? Early safety signal detection enables: Early identification of safety risks Informed decision making Meets...
Challenges in Clinical Development of Products for Rare Disease
Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. There are over 7,000 rare diseases affecting more than 30 million...
Leveraging Single-Arm Trials for Regulatory Approval: Insights from EMA's Reflection Paper
The pharmaceutical industry has shown a growing interest in single-arm trials due to their potential to expedite drug development. However, several challenges and concerns remain. The European...
Do regulations and guidance documents sometimes stagnate your learning progress because of the terminology used? Regulation confusion is a common complaint heard from current and prospective new...
Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance
In the world of clinical and biological research programs, ensuring compliance with regulatory standards is not only essential for maintaining the integrity of studies but also for safeguarding the...
Drug Development: The Key to Success from Concept to US Commercialization
Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science and effort to get to this stage is significant....
The Importance of Social Media Monitoring in Pharma
In today's digital age, social media has transformed how businesses communicate with their audiences. For pharmaceutical companies, this shift presents both challenges and opportunities. Social media...
Pre-Approval Inspection (PAI) Readiness is Easy, Right?
Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with...
European Pharma Regulations: 2024 Review and 2025 Trends to Watch
Gaining a Competitive Edge: 2024's European Pharma Regulatory Review & Trends to Look for in 2025 and Beyond As the pharmaceutical landscape in Europe evolves rapidly, regulatory frameworks are...
Optimizing Clinical Trials: Balancing Patient Experience and Commercial Outcomes with Concierge Services
As therapies for rare diseases evolve, clinical trials increasingly require patient -centric care to ensure a smooth and supportive participant experience. This shift is crucial not only for...
WHO Issues Guidance on Antibiotic Pollution Control
On September 3, 2024, the World Health Organization (WHO) released its first guidance to mitigate antibiotic pollution from manufacturing. This directive, which outlines wastewater and solid waste...
Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights
As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a...
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...
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...
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...
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...
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...
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...
The QPPV: An Essential Guide to the Qualified Person Responsible for Pharmacovigilance
When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...