Part 1 – Medical Device DesignJune is our month to examine how new medical devices are approved. In this 4-part series we’ll focus on FDA regulatory pathways, although much of what we discuss can be applied in other jurisdictions. Global harmonization of device...
Product Development
New Medicine Development
Part 1 - DiscoveryMay is our month to review how new medicines are developed. This will be an eight part series describing the different stages of drug development which are applicable in all regulatory jurisdictions.The aim of discovery research is to clearly...
Device Submissions Are Now All Electronic
eSubmitter Tool In December, the FDA issued a final rule revising all the regulations for medical device regulatory submissions to replace paper with electronic copies. An update to the eCopy Guidance was issued with the rule, along with updates to guidance on...
Setting Drug Expiration Dates
Have you ever wondered how the expiration date is determined for a pharmaceutical product you’ve used? Whether prescription or over the counter, all medications have their expiration dates determined through a stability program in which batches of the product are held...
Standards Organizations Play a Role in Medical Product Regulation
Regulatory bodies worldwide make use of consensus standards developed by independent organizations to establish best practices and conceptual harmony on specialized areas of expertise. Standards organizations for drugs include the regional Pharmacopeia USP, EP, and JP...
Using Inspection Procedures & Guides as a Preparation Tool for Medical Device Inspection
If you are involved in the development or manufacturing of a medical product, sooner or later, you will face a regulatory inspection. The individual regulatory agencies publish many of their inspection procedures online, and these documents are valuable references for...
Three-Tiered Approach to Regulation of Next Generation Sequencing
With the recent approval of three new next generation sequencing diagnostic tests for tumor profiling, CDRH also announced their approach to regulating such tests. There are three levels of validated biomarkers addressed in each of the market authorizations for the...
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...