Traditionally, pharmacopoeia is a book of medicinal drugs with their effects and directions for use. Today, the pharmacopoeia are regional organizations devoted to creating and maintaining standards to ensure public health. Part of that mission includes maintaining a...
Medical Products
2020 Good for Pharmaceuticals and Life Sciences Deals?
There’s a lot of investment capital floating around out there, and the Pharmaceuticals and Life Sciences (PLS) sector could benefit this year. According to a report by international accounting firm PwC, there’s considerable money and investment interest in the space,...
Do Value Based Agreements Ensure Patient Access To New Medicines?
Alnylam Pharmaceuticals recently announced a new Value Based Agreement (VBA) framework for their newly approved RNAi medicine to treat acute hepatic porphyria, a group of rare genetic diseases due to one or more deficiencies in the heme biosynthesis pathway in the...
Cybersecurity for Medical Devices Part 2
Conduct Your Risk Assessment Using the CVSS Standard Management of cybersecurity across the lifecycle of a medical device includes repeat assessments of the device’s vulnerabilities, categorization of their severity, and prioritizing risk mitigation and controls. The...
What is a Drug Master File (DMF)?
A Drug Master File, or DMF, is a submission to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. There are four types of DMFs: Type...
Streamlined Process for Investigational In Vitro Devices
Codeveloped with Oncology Drugs The FDA released a procedural guidance in October 2019 which provides a streamlined process for submitting investigational in vitro devices (IVD) being codeveloped with investigational drugs in the same clinical protocol. The process...
New Modules posted on CDRH Learn
CDRH posted seven new modules on the CDRH Learn web page at the end of September/beginning of October. These new modules are: Under The Basics How is CDRH Structured? Is My Product a Medical Device? Under How to Study and Market Your Device Introduction to the...