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Because the FDA is an agency established by a federal law, there are clearly defined pathways along which a drug can be approved. Deciding on the appropriate regulatory pathway for your drug...
Full-Service CRO
The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices....
Quality & Compliance
How quickly the auditing landscape has changed! Less than one year ago if ProPharma were asked to perform a clinical audit on your firm’s behalf, we would reply with "when, what, and where?" Today...
Full-Service CRO
COVID-19 has been the ultimate Big Pharma catalyst, as well as the biggest thing to hit biopharmaceutical news pages in decades. On the industry side, however, investors and observers remain mindful...
Quality & Compliance
On July 21st, 2020, the FDA released a draft guidance document for developers of cannabis and cannabis derived compounds, aptly titled “Cannabis and Cannabis Derived Compounds: Quality Considerations...
Full-Service CRO
If you are interested in data integrity, you likely have read many articles about the topic. This blog delivers 7 new insights to data integrity, looking at it from different angles. Seven ways to...
Are you using Microsoft Excel spreadsheets for GxP activities? Are these Excel sheets used again and again, as a template? Ever thought about validating your spreadsheet templates? Is the person who...
Full-Service CRO
It's no wonder scientists begin clinical trials with great excitement: combine promising discoveries with the best test sites, scientists, and as many qualified, willing patients as possible, and off...
Regulatory Sciences
On Friday, July 11th, Stephen Hahn, MD, Commissioner of the FDA, issued a Coronavirus (COVID-19) Update, announcing the Agency's plans to resume "prioritized domestic inspections of FDA-regulated...
Full-Service CRO
An abbreviated new drug application (ANDA) is a “streamlined” marketing application that is submitted to the FDA for review containing information and data about a generic drug product. Once...
Quality & Compliance
The COVID-19 pandemic revealed a structural weakness in many products' supply chains. In terms of supply of pharmaceutical products, supply shocks were not mitigated when intermediates or production...
Full-Service CRO
Today, with the FDA endorsing fewer new treatments, life sciences companies are pressured to develop better therapies while also struggling to control costs and retain their star employees. And while...
Quality & Compliance
When conducting a clinical trial, there are many aspects sponsors need to be aware of with regards to clinical safety, product efficacy, and the ability to bring treatments through the multiple...
Regulatory Sciences
On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19. The...
Quality & Compliance
The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...
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...
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...
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...