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The deadline to comply with the revised EudraLex Volume 4, Annex 1 is August 25th, 2013. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...
Clinical Research Solutions
This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...
Clinical Research Solutions
This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...
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...
Recently, there have been two notable cases regarding pharmaceutical advertising code violations based on LinkedIn content. It was announced that Danish drugmaker Novo Nordisk has been suspended by...
Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...
This article has been updated since its original publication date. Product development is an extremely time consuming and challenging process for any pharmaceutical, biotechnology, or medical device,...
Clinical Research Solutions
This article has been updated since its original publication date. ProPharma holds its own MIA licenses both in the Netherlands to cover batch importation and Qualified Person (QP) batch...
ProPharma applauds the myriad of recent, positive developments for clinical trials in the UK, representing the biggest overhaul in UK clinical trials in two decades. Lord O’Shaughnessy Clinical Trial...
Clinical Research Solutions
MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of effectiveness the Modernization of Cosmetics Regulation Act of 2022 or "MoCRA" was...
How do we improve outcomes for an uncommon healthcare challenge in a community challenged with common healthcare issues? The Orphan Drug Act defines a rare disease as a disease or condition that...
After panning over the Boston Business Journal and seeing yet another local VC (Venture Capital) firm raise a record $350 million in venture capital for Massachusetts life science, I asked myself:...
Does your organization conduct or outsource testing to an Animal Research Facility? If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...
Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...
According to FDA's clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...
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...
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...
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...
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...