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What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...
Is your project schedule ready to pass the Project Management Institute’s (PMI) "litmus test"? Not sure? Well, the Project Management Team at ProPharma is here to lend a helping hand. Below are some...
Regulatory Sciences
The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...
A common principle in Operational Qualification (OQ) studies is to challenge processes under worst case conditions. A "worst case" condition or set of conditions are generally those parameters...
Quality & Compliance
Believe it or not, project bullying in the workplace does exist. It is not a threat only at schools and on playgrounds. Project bullying can come for any source including the Project Manager, the...
Full-Service CRO
So what’s all the hub-bub about Digital Health? Is it really as big as they say? Is it just a fad? Is it all hype? Well, my answer is yes to all of the above. As with all major new technologies and...
Full-Service CRO
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...
On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...
Regulatory Sciences
Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...
In the space of a few years, Medical Information outsourcing has moved from being a last resort to become a core part of the service delivery strategy for most pharmaceutical companies. The speed of...
I was recently asked to review a report summarizing the historic performance of a pharmaceutical process. The report consisted of the usual data tables and charts, but one thing caught my eye: data...
Full-Service CRO
The commissioning process is defined as "a quality-focused process for enhancing the delivery of a project. The process focuses upon verifying and documenting that all of the commissioned systems and...
FDA is investigating the use of tramadol, a narcotic-like pain reliever, in children aged 17 years and younger after learning of the “rare but serious” risk of slowed or difficult breathing....
Generating process data is expensive: Costs include materials, process time and the focus of highly-compensated subject matter experts. Unfortunately, many organizations don’t get their money’s worth...
Quality & Compliance
In the previous installment of this blog, we discussed the importance of establishing a Master Validation Plan, and how to plan and assess your validation approach. Today’s segment will complete the...
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...
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...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...