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Clinical Research Solutions
When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a...
Clinical Research Solutions
In response to the COVID-19 pandemic, global regulatory authorities adopted a pragmatic virtual auditing approach. This approach includes the flexibility and procedural simplifications to maintain...
Clinical Research Solutions
Preventive vaccines are a special kind of medicinal product, as they are administered before a disease instead of during. You are probably familiar with preventive vaccines from your own or your...
Clinical Research Solutions
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...
Clinical Research Solutions
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....
Clinical Research Solutions
How quickly the auditing landscape has changed! Less than one year ago if ProPharma Group were asked to perform a clinical audit on your firm’s behalf, we would reply with “when, what, and where?”...
Clinical Research Solutions
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...
Clinical Research Solutions
On July 21st, 2020, the FDA released a draft guidance document for developers of cannabis and cannabis derived compounds, aptly titled “Cannabis and Cannabis Derived Compounds: Quality Considerations...
Quality & Compliance
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...
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...
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...
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...
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...
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...
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...