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Clinical Research Solutions
On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019. Prescription Drug Application Fees According to the Food, Drug, & Cosmetic (FD&C)...
Medical Information
Market Access, Pricing, and Additional Compliance Considerations In part one, we explored the German pharmaceutical market and regulatory compliance requirements. Now, in part two, we will focus on...
Medical Information
The COVID-19 pandemic challenged nearly every aspect of healthcare delivery—and medical information (MI) services were no exception. As patients and healthcare professionals (HCPs) urgently sought...
Quality & Compliance
Regulatory Considerations and Market Entry Germany is home to one of the most advanced healthcare systems in the world, making it an attractive but complex market for pharmaceutical companies. A...
Medical Information
In the dynamic and ever-evolving pharmaceutical industry, the provision of accurate and reliable Medical Information services (MI) is paramount. These services are crucial for healthcare...
Pharmacovigilance
For Marketing Authorisation Holders (MAHs) planning to market medicinal products in the Netherlands, compliance with local pharmacovigilance (PV) regulations is essential. At ProPharma, we understand...
R&D Technology
While AI has been topping the agenda at most industry events for several years now, the progression from futuristic vision to nearly commodity capability was particularly apparent at BioIT World...
Regulatory Sciences
It is easy to think that when you finally receive market approval for your drug, you have reached the finish line. However, what many do not realize is that there is still a final hurdle that can be...
Pharmacovigilance
As we continue exploring pharmacovigilance (PV) requirements in the DACHL region, this second part of the blog series covers the local roles and obligations in Switzerland and Liechtenstein. While...
Regulatory Sciences
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...
Clinical Research Solutions
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...
Medical Information
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...
Regulatory Sciences
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...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...