Medical Device
The Quick Program speeds up 510(k) Reviews
The FDA recently launched a new pilot program called Quality in 510(k) or Quik that allows manufacturers of moderate risk […]
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Analytical Chemistry, Medical Device, Microbiology, Toxicology
The EU’s Medical Device Regulation (MDR)
The European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be […]
Biologics
Gene Therapy – The Expanding Pipelines and New Draft Guidance Documents
Gene therapy has broken out of its chains. In 2017 alone, Kymriah (Novartis), Luxturna (Spark), and Yescarta (Kite Pharma/Gilead) received […]
Analytical Chemistry, Biologics, Medical Device, Pharmaceuticals
Pacific BioLabs Purchases SciEx TripleTOF 5600 High Resolution Mass Spec System
The SciEx TripleTOF 5600 Mass Spectrometer is known for delivering excellent sensitivity and linear
dynamic range. In highly complex matrices, the […]
Medical Device
Reusable Device Cleaning Validation – Three Cycles or One Cycle?
Pacific BioLabs have been performing reusable device cleaning validations for over a decade. Traditionally, PBL has performed cleaning validations by […]
Medical Device
FDA Decision to Exempt Certain Class II Devices from 510(k) Premarket Notification
On July 11th, 2017 the FDA announced that they have determined that certain class II device will no longer meet […]
Analytical Chemistry, Toxicology
Maximum Tolerated Dose (MTD) – An effective preclinical dose determination strategy
The path to drug approval involves drug discovery and drug development. In drug discovery, compounds are screened for favorable biological […]
Biologics, Medical Device, Pharmaceuticals
Insulin and Glucagon Bioassays
With the prevalence of diabetes increasing worldwide at unprecedented rates in recent decades, the development of relevant drug therapies have […]
Medical Device, Pharmaceuticals
USP 661 Plastic Packaging: Introduction to <661.1> and <661.2>
Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may […]
Analytical Chemistry, Pharmaceuticals
CASE STUDY : CHALLENGES IN METHOD DEVELOPMENT FOR DRUG INTERACTION STUDIES
Current FDA guidance indicates that drug interactions should be "defined during drug development, as part of an adequate assessment of the […]